GB2569997A - Improvements relating to intravenous fluids - Google Patents
Improvements relating to intravenous fluids Download PDFInfo
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- GB2569997A GB2569997A GB1800318.6A GB201800318A GB2569997A GB 2569997 A GB2569997 A GB 2569997A GB 201800318 A GB201800318 A GB 201800318A GB 2569997 A GB2569997 A GB 2569997A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7004—Monosaccharides having only carbon, hydrogen and oxygen atoms
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/14—Alkali metal chlorides; Alkaline earth metal chlorides
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/12—Drugs for disorders of the metabolism for electrolyte homeostasis
Abstract
An aqueous composition suitable for intravenous administration to a patient. The aqueous composition comprising 40-60 mmol/L sodium, 20-45 mmol/L potassium, and 2-12 wt% carbohydrate. In addition, the packaged solution contains 200-2000ml of water and the aqueous composition is suitable for use in maintaining homeostasis in a patient. The solution may be administered at a rate of 25-35 ml per kg of patient bodyweight over a 24 hour period. Alternatively, the solution can be administered to the patient at a rate such that 1.3-2.0 mmol of sodium ions and 0.8-1.2 mmol potassium ions per kg of said patient’s bodyweight per 24 hour period. The solution can contain dextrose, fructose, or galactose as the carbohydrate source. The potassium ions may be provided by KCl and the sodium ions provided by NaCl.
Description
Improvements Relating to Intravenous Fluids
Field
The present invention relates to an aqueous composition for intravenous administration to a patient in need thereof for maintaining homeostasis in said patient. The present invention also relates to methods and uses involving said aqueous composition. In particular the invention relates to an aqueous composition for maintaining homeostasis in a patient unable to receive food and water orally, for example after surgery.
Background
Homeostasis in a human or animal body is a process of maintaining a constant internal environment in the body. An important aspect of homeostasis is the control of fluid and electrolyte levels in the body which is performed mainly by the kidneys. Homeostasis of fluid and electrolytes requires a regular intake of water and essential constituents, most importantly sodium and potassium. Homeostasis more generally also requires the regular intake of carbohydrate, such as dextrose, to maintain basic cellular metabolism.
There are many situations in clinical practice where a patient is prevented from receiving food and water orally, for example after some types of bowel surgery, whilst awaiting emergency surgery or if unable to swallow properly after a stroke. In such circumstances the patient may not be able to maintain homeostasis effectively and therefore the administration of a fluid mixture to maintain homeostasis and cellular metabolism is desirable.
Furthermore, fluid loss may occur before or during a surgical procedure due to vomiting, diarrhoea, bowel preparation before surgery (purging), direct fluid loss during surgery and general unmeasured losses when the patient’s body cavity is open. Therefore in order to maintain homeostasis whilst a patient is unable to receive food and water orally, for example before and after surgery, it is necessary to intravenously administer fluids containing the essential constituents to the patient. If homeostasis is not adequately maintained during such a period then a range of complications can arise in the patient, including hypovolemia and hyperchloraemic acidosis.
Currently available aqueous compositions used for intravenous administration to patients include saline 0.9% and Hartmann’s solution. Saline 0.9% is an aqueous composition comprising 154 mmol/l of sodium chloride. Hartmann’s solution is an aqueous composition comprising 102 mmol/l sodium chloride, 29 mmol/l sodium lactate, 5 mmol/l potassium chloride, 2 mmol/l calcium chloride and 50 g/l of glucose. Typically such aqueous compositions are available in one litre and 500 ml packages.
Previously, it was common practice to add other constituents to such packages of aqueous compositions before or during intravenous administration to a patient. For example, a practitioner may have added a solution of potassium chloride to a package of saline 0.9% in order to provide the patient with the essential potassium required for homeostasis. However, due to safety concerns, adulterating a package of aqueous composition intended for intravenous administration in this manner is no longer permitted, in the UK at least. Therefore, medical practitioners have to use the currently available packages of aqueous composition, such as saline 0.9% and Hartmann’s solution during surgery. Such solutions may not provide the optimum combination of essential constituents for maintaining homeostasis in a patient, particularly after surgery.
Summary of the Invention
The inventor has recognised that a human patient requires approximately the following amounts of essential constituents per kilogram of the patient’s bodyweight per 24 hour period to maintain homeostasis: 1.5 mmol of sodium ions, 1 mmol of potassium ions and 30 ml of water. The inventor has also recognised a discrepancy between these ideal amounts of essential constituents required for homeostasis of a patient and the concentrations of said essential constituents present in currently available aqueous compositions suitable for intravenous administration to patients. This makes it difficult to provide the correct amounts of essential constituents required for homeostasis to a patient using currently available aqueous compositions, often resulting in patients receiving non-ideal amounts of said essential constituents which may lead to adverse complications in patients.
For example, a low concentration of sodium and potassium can be life threatening to a patient. A relatively low concentration of sodium in a patient’s circulation (hyponatraemia) can lead to swelling of the brain (cerebral oedema) causing fatal convulsions. A relatively low concentration of potassium in a patient’s circulation (hypokalaemia) can affect electrical conduction in the heart, potentially leading to fatal irregular heart rhythms (dysrhythmias). A relatively high concentration of sodium chloride can lead to acidosis of the blood which may affect organ function and cause a distressing level of thirst.
It is therefore one aim of the present invention, amongst others, to provide an aqueous composition suitable for intravenous administration to a patient that addresses at least one disadvantage of the prior art, whether identified here or elsewhere, or to provide an alternative to existing aqueous compositions. For instance it may be an aim of the present invention to provide an aqueous composition which can deliver to a patient, from a single package, the essential constituents in specific concentrations required for homeostasis and which may be particularly useful for maintaining homeostasis in a patient unable to receive food and water orally, for example before or after surgery.
According to aspects of the present invention, there is provided an aqueous composition, method and use as set forth in the appended claims. Other features of the invention will be apparent from the dependent claims, and the description which follows.
According to a first aspect of the present invention, there is provided an aqueous composition suitable for intravenous administration to a patient, the aqueous composition comprising: from 40 to 60 mmol/l of sodium ions; from 20 to 45 mmol/l of potassium ions; and from 2 to 12 wt% of a carbohydrate.
Such aqueous compositions are suitably provided in sterile packages, such as flexible bags/pouches or glass vessels, which are then connected to suitable tubing, said tubing being in fluid communication with a patient’s bloodstream, for example through a cannula. The aqueous compositions of this first aspect may be additionally or alternatively defined as “intravenous fluids”. Such aqueous compositions are synthetically prepared and therefore not part of or taken from the body of a human or animal. Suitably the aqueous compositions are sterile, being manufactured under sterile conditions, and do not comprise any biological material or direct products of biosynthesis. Any components of biological origin contained in the aqueous compositions, for example the carbohydrate, are first isolated, purified, made sterile and then introduced into the aqueous composition during manufacture.
The aqueous composition may also be referred to as an aqueous solution. Suitably the constituents of the aqueous composition of this first aspect are completely dissolved in the aqueous composition. Therefore the aqueous composition of this first aspect is suitably an aqueous solution.
Such aqueous compositions are used in a range of clinical situations to provide patients with the necessary fluids to either replace fluids lost due to injury or illness or to maintain homeostasis. The aqueous compositions of this first aspect may be particularly suitable for providing sufficient fluid and essential constituents to enable a patient to maintain homeostasis, in particular before or after surgery or if unable to swallow.
The inventor has found that the aqueous composition of this first aspect with the specific amounts of sodium ions, potassium ions and a carbohydrate, may be particularly effective in allowing a patient to maintain homeostasis during a period wherein the patient is prevented from eating and drinking normally, for example before or after surgery. Therefore the aqueous composition of this first aspect may allow the patient to avoid complications associated with poor fluid and electrolyte management. The aqueous compositions of this first aspect may provide concentrations of sodium ions, potassium ions and carbohydrate in water which, when delivered intravenously at a set rate over a certain period of time, more closely correlate with the needs of the human body for homeostasis over said period of time, compared to known intravenous fluids. Therefore in order to maintain homeostasis in a patient, a clinician need only deliver intravenously the aqueous composition according to this first aspect, at a set rate over a certain period of time. It would be difficult or impossible for a clinician to achieve the same rate of delivery of sodium ions, potassium ions and carbohydrate using known aqueous solutions. A clinician may attempt to achieve the same overall delivery of sodium ions, potassium ions and carbohydrate over said period of time using known aqueous solutions, which when averaged out over said period of time would correlate reasonably closely with the needs of the human body for maintaining homeostasis. However, this would require the use of several different such known aqueous compositions over said period of time or would require adulteration of such known aqueous compositions, which is no longer permitted in the UK at least. Even using such methods, it would be difficult for a clinician to provide the optimum concentrations of sodium ions, potassium ions and carbohydrate to maintain homeostasis during before and/or after surgery.
Therefore the aqueous composition of the first aspect may provide significant advantages for the clinician and patient compared to known aqueous compositions, particularly in maintaining homeostasis in the perioperative period. The present invention may provide a more straightforward fluid regime for patients before and/or after surgery which can be more easily implemented by clinical staff compared to when using known aqueous compositions.
The aqueous composition of this first aspect may be used in patients having a wide range of different bodyweights. In order to provide sufficient sodium ions, potassium ions and carbohydrate to meet the needs of the patient for homeostasis over a period of time, it would be necessary to provide the aqueous composition at a higher rate to a patient having a larger bodyweight than would be necessary for a patient with a smaller bodyweight. For example, the aqueous composition may be delivered intravenously to a patient at a rate of 30 ml per 24 hour period per kg of the patient’s bodyweight.
The sodium ions and the potassium ions of the aqueous composition of this first aspect may be provided by any suitable source, for example by ionic salts dissolved in the aqueous composition.
Suitably the sodium ions are provided by a sodium salt, suitably NaCl.
The aqueous composition of this first aspect comprises from 40 to 60 mmol/l of sodium ions, suitably from 40 to 60 mmol/l of NaCl. Suitably the aqueous composition comprises from 45 to 55 mmol/l of the sodium ions, suitably approximately 50 mmol/l, suitably 50 mmol/l.
Suitably the aqueous composition comprises from 45 to 55 mmol/l of NaCl, suitably approximately 50 mmol/l of NaCl, suitably 50 mmol of NaCl.
Suitably the potassium ions are provided by a potassium salt, suitably KCI.
The aqueous composition of this first aspect comprises from 20 to 45 mmol/l of potassium ions, suitably from 20 to 45 mmol/l of KCI. Suitably the aqueous composition comprises from 25 to 40 mmol/l of potassium ions, suitably from 30 to 35 mmol/l, suitably approximately 33 mmol/l.
Suitably the aqueous composition comprises from 25 to 40 mmol/l of KCI, suitably from 30 to 35 mmol/l of KCI, suitably approximately 33 mmol/l of KCI, suitably 33 mmol of KCI or 33.3 mmol of KCI.
The aqueous composition of this first aspect comprises a carbohydrate. The carbohydrate suitably provides sufficient energy for a patient to maintain cellular metabolism during the period of administration of the aqueous composition. Suitably the carbohydrate is selected from dextrose, fructose, and galactose. Suitably the carbohydrate is dextrose.
Suitably the aqueous composition comprises from 2 to 12wt% of the carbohydrate, suitably from 4 to 10 wt%, suitably from 4 to 8 wt%, suitably approximately 5 wt%, suitably 5 wt%.
Suitably the aqueous composition comprises from 2 to 12 wt% of dextrose, suitably from 4 to 10 wt%, suitably from 4 to 8 wt%, suitably approximately 5 wt%, suitably 5 wt%.
In one embodiment the aqueous composition comprises: approximately 50 mmol/l of sodium ions; approximately 33 mmol/l of potassium ions; and from 2 to 12 wt% of a carbohydrate.
Suitably the aqueous composition comprises: 50 mmol/l of sodium ions; 33 mmol/l of potassium ions; and from 2 to 12 wt% of a carbohydrate.
Suitably the aqueous composition of this first aspect consists essentially of the above mentioned constituents.
In one embodiment, the aqueous composition of this first aspect comprises: from 45 to 55 mmol/l of NaCl; from 30 to 35 mmol/l of KCI; and from 2 to 12 wt% of a carbohydrate, suitably dextrose.
Suitably the aqueous composition comprises: approximately 50 mmol/l of NaCl; approximately 33 mmol/l of KCI; and approximately 5 wt% of a carbohydrate, suitably dextrose.
Suitably the aqueous composition comprises: 50 mmol/l of NaCl; 33 mmol/l of KCI; and 5 wt% of a carbohydrate, suitably dextrose.
In one embodiment, the aqueous composition of this first aspect consists essentially of: from 45 to 55 mmol/l of NaCl; from 30 to 35 mmol/l of KCI; and from 2 to 12 wt% of a carbohydrate, suitably dextrose.
In one embodiment, the aqueous composition of this first aspect consists essentially of: approximately 50 mmol/l of NaCl; approximately 33 mmol/l of KCI; and approximately 5 wt% of a carbohydrate, suitably dextrose.
Suitably the aqueous composition of this first aspect consists essentially of: 50 mmol/l of NaCl; 33 mmol/l of KCI; and 5 wt% of a carbohydrate, suitably dextrose.
In some embodiments, the aqueous composition comprises from 6 to 12wt% of the carbohydrate, suitably from 8 to 12 wt%, suitably approximately 10 wt%, suitably 10 wt%.
In some embodiments, the aqueous composition comprises from 6 to 12wt% of dextrose, suitably from 8 to 12 wt%, suitably from 8 to 12 wt%, suitably approximately 10 wt%, suitably 10 wt%.
In one embodiment, the aqueous composition comprises: approximately 50 mmol/l of sodium ions; approximately 33 mmol/l of potassium ions; and from 6 to 12 wt% of a carbohydrate.
Suitably the aqueous composition comprises: 50 mmol/l of sodium ions; 33 mmol/l of potassium ions; and from 6 to 12 wt% of a carbohydrate.
Suitably the aqueous composition of this first aspect consists essentially of the above mentioned constituents.
In one embodiment, the aqueous composition of this first aspect comprises: from 45 to 55 mmol/l of NaCl; from 30 to 35 mmol/l of KCI; and from 6 to 12 wt% of a carbohydrate, suitably dextrose.
Suitably the aqueous composition comprises: approximately 50 mmol/l of NaCl; approximately 33 mmol/l of KCI; and approximately 10 wt% of a carbohydrate, suitably dextrose.
Suitably the aqueous composition comprises: 50 mmol/l of NaCl; 33 mmol/l of KCI; and 10 wt% of a carbohydrate, suitably dextrose.
In one embodiment, the aqueous composition of this first aspect consists essentially of: from 45 to 55 mmol/l of NaCl; from 30 to 35 mmol/l of KCI; and from 6 to 12 wt% of a carbohydrate, suitably dextrose.
In one embodiment, the aqueous composition of this first aspect consists essentially of: approximately 50 mmol/l of NaCl; approximately 33 mmol/l of KCI; and approximately 10 wt% of a carbohydrate, suitably dextrose.
Suitably the aqueous composition of this first aspect consists essentially of: 50 mmol/l of NaCl; 33 mmol/l of KCI; and 10 wt% of a carbohydrate, suitably dextrose.
Suitably in the above descriptions of the aqueous composition of this first aspect, the balance of the composition is provided by water. Suitably the aqueous composition of this first aspect comprises from 200 to 2000 ml of water.
In one embodiment, the aqueous composition comprises approximately 1 litre of water, suitably 1 litre.
In one embodiment, the aqueous composition comprises approximately 500 ml of water, suitably 500 ml.
The inventor has found that an aqueous composition comprising these particular amounts of the essential constituents can be particularly effective in maintaining homeostasis in a patient when administered intravenously, especially before and/or after surgery. These specific concentrations of sodium ions/NaCI, potassium ions/KCI and carbohydrate/dextrose may provide an optimum amount of these essential constituents for maintaining homeostasis in a patient when the aqueous composition is used appropriately. These specific embodiments may therefore be particularly advantageous over known aqueous compositions suitable for intravenous administration.
Suitably the aqueous solution is a crystalloid solution. Therefore the aqueous solution suitably consists essentially of water and water soluble constituents, for example mineral salts and carbohydrates.
The aqueous composition of this first aspect may be prepared using known methods for the manufacture of known aqueous compositions suitable for intravenous administration to patients, with the types and amounts of constituents varied accordingly. Therefore with the knowledge of the amounts of the essential constituents of the aqueous composition of this first aspect provided by this disclosure, a person skilled in the art would be able to use said known methods to prepare the aqueous composition of this first aspect.
Suitably the aqueous composition of this first aspect is not adulterated after manufacture by the addition of any substances, particularly any sodium ions, potassium ions or dextrose.
According to a second aspect of the present invention there is provided a packaged aqueous composition suitable for intravenous administration to a patient, the packaged aqueous composition comprising: from 40 to 60 mmol/l of sodium ions; from 20 to 45 mmol/l of potassium ions; from 2 to 12 wt% of a carbohydrate; and from 200 to 2000 ml of water.
The packaged aqueous composition of this second aspect may have any of the suitable features and advantages described in relation to the aqueous composition of the first aspect.
In one embodiment, the packaged aqueous composition comprises approximately 1 litre of water. Suitably the volume of the aqueous solution of the packaged aqueous composition is approximately 1 litre, suitably 1 litre.
In one embodiment, the packaged aqueous composition comprises approximately 500 ml of water. Suitably the volume of the aqueous solution of the packaged aqueous composition is approximately 500 ml, suitably 500 ml.
Suitably the packaged aqueous composition may comprise a package known in the art which is suitable for containing and administering fluids intravenously, for example a sterile hanging bag comprising a tap or valve.
The packaged aqueous composition of this second aspect may be prepared using known methods for the manufacture of known packaged aqueous compositions suitable for intravenous administration to patients, with the types and amounts of constituents varied accordingly. Therefore with the knowledge of the amounts of the essential constituents of the packaged aqueous composition of this second aspect provided by this disclosure, a person skilled in the art would be able to use said known methods to prepare the packaged aqueous composition of this second aspect.
Suitably the packaged aqueous composition of this second aspect is not adulterated after manufacture by the addition of any substances, particularly any sodium ions, potassium ions or carbohydrate.
According to a third aspect of the present invention, there is provided an aqueous composition for use in maintaining homeostasis in a patient in need thereof by intravenous administration of the aqueous composition to said patient, the aqueous composition comprising: from 40 to 60 mmol/l of sodium ions; from 20 to 45 mmol/l of potassium ions; and from 2 to 12 wt% of a carbohydrate.
The aqueous composition used in this third aspect may have any of the suitable features and advantages described in relation to the aqueous composition of the first aspect.
The inventor has found that the aqueous composition of the present invention is effective in maintaining homeostasis in a patient in need thereof, for example before of after surgery.
Suitably the aqueous solution is administered to said patient at a rate of from 25 to 35 ml per kg of said patient’s bodyweight per 24 hour period. Suitably the aqueous solution is administered to said patient at a rate of from 27.5 to 32.5 ml per kg of said patient’s bodyweight per 24 hour period, suitably at a rate of approximately 30 ml per kg of said patient’s bodyweight per 24 hour period, suitably at a rate of 30 ml per kg of said patient’s bodyweight per 24 hour period.
The aqueous composition of the present invention may be administered to a patient at the specified rates using standard known equipment for the intravenous administration of aqueous compositions, for example using an infusion pump which can be adjusted to deliver such aqueous compositions at a specified rate.
The inventor has found that using the rates of administration of the aqueous composition as described above based on the patient’s bodyweight, sufficient amounts of the essential constituents contained therein are provided to the patient in order to maintain homeostasis for the period of time during which intravenous fluids are required. Using these rates, a clinician can easily establish the rate at which to administer the aqueous composition to a particular patient.
The rates of administration described above may be particularly suitable for patients with a bodyweight in the range of from 40 to 100 kg. For a patient with a bodyweight outside this range alternative rates of administration may be preferable. For patients with a bodyweight above 100 kg it may be preferable to administer the aqueous composition at a rate of 3 litres per 24 hour period.
Suitably the aqueous solution is administered to said patient at a rate which provides said patient with: from 0.7 to 2.0 mmol of sodium ions per kg of said patient’s bodyweight per 24 hour period; and from 0.5 to 1.5 mmol of potassium ions per kg of said patient’s bodyweight per 24 hour period.
Suitably the aqueous solution is administered to said patient at a rate which provides said patient with from 0.7 to 1.7 mmol of sodium ions per kg of said patient’s bodyweight per 24 hour period, suitably from 0.9 to 1.6 mmol of sodium ions.
In some embodiments, the aqueous solution is administered to said patient at a rate which provides said patient with from 1.4 to 1.6 mmol of sodium ions per kg of said patient’s bodyweight per 24 hour period, suitably approximately 1.5 mmol of sodium ions per kg of said patient’s bodyweight per 24 hour period, suitably 1.5 mmol of sodium ions per kg of said patient’s bodyweight per 24 hour period.
Suitably the aqueous solution is administered to said patient at a rate which provides said patient with from 0.8 to 1.2 mmol of potassium ions per kg of said patient’s bodyweight per 24 hour period, suitably from 0.9 to 1.1 mmol, suitably approximately 1.0 mmol of potassium ions per kg of said patient’s bodyweight per 24 hour period, suitably 1.0 mmol of potassium ions per kg of said patient’s bodyweight per 24 hour period.
The inventor has recognised that the above described rates of sodium ion and potassium ion administration are necessary to effectively maintain homeostasis in patients in need thereof. These rates of sodium ion and potassium ion administration would not be provided by the use of a single unadulterated type of an known aqueous composition.
Suitably the use in maintaining homeostasis in a patient in need thereof is in a patient who is unable to receive food and water orally due a medical condition and/or a medical treatment regime.
Suitably the use in maintaining homeostasis in a patient in need thereof is in a patient who is about to undergo surgery or who has undergone surgery.
Suitably the patient is in a perioperative period when the aqueous composition of the present invention is administered.
Suitably the use of this third aspect is for the prevention of hyperchloraemic acidosis.
The use of known aqueous compositions for the maintenance of homeostasis in a patient may result in the administration of too much chloride to the patient, the chloride being present in said known aqueous compositions as the counter ion for the sodium and potassium ions, if present. This may cause hyperchloraemic acidosis in the patient which can be avoided by use of the aqueous composition of the present invention in the amounts and rates discussed above.
Suitably the use of this third aspect is for the prevention of hypovolemia. Suitably the use of this third aspect is for the prevention of hyperchloraemic acidosis and/or hypovolemia and the complications which may arise from these conditions.
In some embodiments, the use of this third aspect is for the prevention of one or more of hyponatraemia, hypokalaemia, hypernatremia and hyperkalaemia and/or the complications which may arise from these conditions.
The aqueous composition of the present invention is intended for maintenance of homeostasis in a patient. The aqueous composition may therefore be termed a “maintenance fluid”. The aqueous composition may be suitable for use in a patient for up to 2 to 3 days. After this time the patient may require additional nutrients to maintain health. Therefore an alternative aqueous composition may be more suitable, if the patient continues to be unable to feed and drink normally. Furthermore, patients who have suffered significant fluid loss through illness or injury may require alternative types and amounts of essential constituents in order to replace the lost fluids. Therefore the aqueous composition of the present invention may not be suitable for said patients to initially recover the lost fluids. However, the aqueous solution of the present invention may be used at the appropriate time during a patient’s care to provide the advantages described above over known aqueous compositions which may have been used as “maintenance fluids” previously.
Examples
The following examples illustrate how a patient having a particular bodyweight can be treated with the aqueous composition of the present invention in order to allow said patient to maintain homeostasis.
Patient 1 has a bodyweight of 70 kg. The aqueous composition of the present invention preferably comprises 50 mmol of NaCl, 33 mmol of KCI and 5 wt% dextrose. The aqueous composition of the present invention is preferably administered at a rate of 30 ml per kg per 24 hour period. Patient 1 is therefore provided with 2,100 ml of the aqueous composition over a 24 hour period. The aqueous composition is administered to patient 1 using an infusion pump set to an administration rate of 2,100 ml per 24 hours and therefore 87.5 ml per hour. This administration of the aqueous composition to patient 1 provides 105 mmol of sodium ions and 69.3 mmol of potassium ions over the 24 hour period which is equivalent to 1.5 mmol of sodium ions and 1.0 mmol of potassium ions per kg of bodyweight over the 24 hour period. These amounts of sodium ions and potassium ions correlate with the requirements of the patient for maintaining homeostasis identified herein. Therefore treating patient 1 according to the procedure described above may enable patient 1 to maintain homeostasis during the period of administration of the aqueous composition, for example before and/or after surgery.
Patient 2 has a bodyweight of 75 kg. Using the same aqueous composition and administration rate as described for patient 1, patient 2 is provided with 2,250 ml of the aqueous composition over a 24 hour period. The aqueous composition is administered to patient 2 using an infusion pump set to an administration rate of 2,250 ml per 24 hours and therefore 93.8 ml per hour. This administration of the aqueous composition to patient 2 provides 112.5 mmol of sodium ions and 74.3 mmol of potassium ions over the 24 hour period which is equivalent to 1.5 mmol of sodium ions and 1.0 mmol of potassium ions per kg of bodyweight over the 24 hour period. These amounts of sodium ions and potassium ions correlate with the requirements of the patient for maintaining homeostasis identified herein. Therefore treating patient 2 according to the procedure described above may enable patient 2 to maintain homeostasis during the period of administration of the aqueous composition, for example before and/or after surgery.
Patient 3 has a bodyweight of 80 kg. Using the same aqueous composition and administration rate as described for patient 1, patient 3 is provided with 2,400 ml of the aqueous composition over a 24 hour period. The aqueous composition is administered to patient 3 using an infusion pump set to an administration rate of 2,400 ml per 24 hours and therefore 100 ml per hour. This administration of the aqueous composition to patient 3 provides 120 mmol of sodium ions and 79.2 mmol of potassium ions over the 24 hour period which is equivalent to 1.5 mmol of sodium ions and 1.0 mmol of potassium ions per kg of bodyweight over the 24 hour period. These amounts of sodium ions and potassium ions correlate with the requirements of a patient for maintaining homeostasis identified herein. Therefore treating patient 3 according to the procedure described above may enable patient 3 to maintain homeostasis during the period of administration of the aqueous composition, for example before and/or after surgery.
The above examples illustrate how a patient having a bodyweight in the range of from 40 to 100 kg can be effectively treated with an aqueous solution of the present invention using an administration rate of 30 ml per kg per 24 hour period in order to maintain homeostasis during the period of administration of the aqueous solution.
The fluid treatment regimes of patients 1-3 described above illustrate how the aqueous compositions of the present invention provides a clinician with a simple and efficient way of effectively managing the fluid needs of such patients during a certain period. Providing the necessary fluid and electrolytes for homeostasis with such accuracy over a range of relevant body weights is impossible with existing crystalloid products. Therefore the simple and efficient method of the present invention offers significant advantages over methods using known intravenous fluids, both for the clinician and for the patient due to the ease of use and a reduction in complications associated with ineffective fluid management.
In summary, the present invention provides an aqueous composition suitable for intravenous administration to a patient. The aqueous composition comprises sodium, potassium, carbohydrate and water in amounts which correlate with the amounts required to allow a patient to maintain homeostasis, when the aqueous composition is administered at a suitable rate. The aqueous composition suitably comprises from 40 to 60 mmol/l of sodium ions; from 20 to 45 mmol/l of potassium ions; and from 2 to 12 wt% of a carbohydrate. The aqueous composition may be particularly useful in the treatment of patients unable to receive food and water orally, for example before and after surgery. The aqueous composition may provide effective maintenance fluids during such a period. A packaged aqueous composition is also disclosed, along with related treatment information.
Although a few preferred embodiments have been shown and described, it will be appreciated by those skilled in the art that various changes and modifications might be made without departing from the scope of the invention, as defined in the appended claims.
Throughout this specification, the term “comprising” or “comprises” means including the component(s) specified but not to the exclusion of the presence of other components. The term “consisting essentially of’ or “consists essentially of” means including the components specified but excluding other components except for materials present as impurities, unavoidable materials present as a result of processes used to provide the components, and components added for a purpose other than achieving the technical effect of the invention. Typically, when referring to compositions, a composition consisting essentially of a set of components will comprise less than 5% by weight, typically less than 3% by weight, more typically less than 1% by weight of non-specified components.
The term “consisting of” or “consists of’ means including the components specified but excluding addition of other components.
Whenever appropriate, depending upon the context, the use of the term “comprises” or “comprising” may also be taken to encompass or include the meaning “consists essentially of’ or “consisting essentially of’, and may also be taken to include the meaning “consists of’ or “consisting of”.
For the avoidance of doubt, wherein amounts of components in a composition are described in wt%, this means the weight percentage of the specified component in relation to the whole composition referred to. For example, “from 2 to 12 wt% of a carbohydrate” means that from 2 to 12 wt% of the aqueous composition is provided by the carbohydrate.
The optional features set out herein may be used either individually or in combination with each other where appropriate and particularly in the combinations as set out in the accompanying claims. The optional features for each aspect or exemplary embodiment of the invention as set out herein are also to be read as applicable to any other aspect or exemplary embodiments of the invention, where appropriate. In other words, the skilled person reading this specification should consider the optional features for each exemplary embodiment of the invention as interchangeable and combinable between different exemplary embodiments.
Attention is directed to all papers and documents which are filed concurrently with or previous to this specification in connection with this application and which are open to public inspection with this specification, and the contents of all such papers and documents are incorporated herein by reference.
All of the features disclosed in this specification (including any accompanying claims, and drawings), and/or all of the steps of any method or process so disclosed, may be combined in any combination, except combinations where at least some of such features and/or steps are mutually exclusive.
Each feature disclosed in this specification (including any accompanying claims, and drawings) may be replaced by alternative features serving the same, equivalent or similar purpose, unless expressly stated otherwise. Thus, unless expressly stated otherwise, each feature disclosed is one example only of a generic series of equivalent or similar features.
The invention is not restricted to the details of the foregoing embodiment(s). The invention extends to any novel one, or any novel combination, of the features disclosed in this specification (including any accompanying claims, and drawings), or to any novel one, or any novel combination, of the steps of any method or process so disclosed.
Claims (15)
1. An aqueous composition suitable for intravenous administration to a patient, the aqueous composition comprising: from 40 to 60 mmol/l of sodium ions; from 20 to 45 mmol/l of potassium ions; and from 2 to 12 wt% of a carbohydrate.
2. The aqueous composition according to claim 1, wherein the sodium ions are provided by NaCl.
3. The aqueous composition according to claim 1 or claim 2, wherein the potassium ions are provided by KCI.
4. The aqueous composition according to any preceding claim, wherein the carbohydrate is selected from dextrose, fructose, and galactose.
5. The aqueous composition according to any preceding claim, wherein the carbohydrate is dextrose.
6. The aqueous composition according to any preceding claim comprising from 45 to 55 mmol/l of the sodium ions.
7. The aqueous composition according to any preceding claim comprising from 30 to 35 mmol/l of the potassium ions.
8. The aqueous composition according to any preceding claim comprising from 4 to 12 wt% of the carbohydrate.
9. The aqueous composition according to claim 1 wherein: the sodium ions are provided by from 45 to 55 mmol/l of NaCl; the potassium ions are provided by from 30 to 35 mmol/l of KCI; and the carbohydrate is provided by from 2 to 12 wt% of dextrose.
10. A packaged aqueous composition suitable for intravenous administration to a patient, the packaged aqueous composition comprising: from 40 to 60 mmol/l of sodium ions; from 20 to 45 mmol/l of potassium ions; from 2 to 12 wt% of a carbohydrate; and from 200 to 2000 ml of water.
11. An aqueous composition for use in maintaining homeostasis in a patient in need thereof by intravenous administration of the aqueous composition to said patient, the aqueous composition comprising: from 40 to 60 mmol/l of sodium ions; from 20 to 45 mmol/l of potassium ions; and from 2 to 12 wt% of a carbohydrate.
12. The aqueous composition for use in maintaining homeostasis in a patient in need thereof according to claim 11, wherein the aqueous solution is administered to said patient at a rate of from 25 to 35 ml per kg of said patient’s bodyweight per 24 hour period.
13. The aqueous composition for use in maintaining homeostasis in a patient in need thereof according to claim 11 or claim 12, wherein the aqueous solution is administered to said patient at a rate which provides said patient with: from 1.3 to 2.0 mmol of sodium ions per kg of said patient’s bodyweight per 24 hour period; and from 0.8 to 1.2 mmol of potassium ions per kg of said patient’s bodyweight per 24 hour period.
14. The aqueous composition for use in maintaining homeostasis in a patient in need thereof according to any one of claims 11 to 13, wherein the patient is about to undergo or has undergone surgery.
15. The aqueous composition for use in maintaining homeostasis in a patient in need thereof according to any one of claims 11 to 14, wherein the use is for the prevention of hyperchloraemic acidosis.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| GB1800318.6A GB2569997A (en) | 2018-01-09 | 2018-01-09 | Improvements relating to intravenous fluids |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| GB1800318.6A GB2569997A (en) | 2018-01-09 | 2018-01-09 | Improvements relating to intravenous fluids |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| GB201800318D0 GB201800318D0 (en) | 2018-02-21 |
| GB2569997A true GB2569997A (en) | 2019-07-10 |
Family
ID=61190454
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| GB1800318.6A Withdrawn GB2569997A (en) | 2018-01-09 | 2018-01-09 | Improvements relating to intravenous fluids |
Country Status (1)
| Country | Link |
|---|---|
| GB (1) | GB2569997A (en) |
Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO1994025059A1 (en) * | 1993-04-30 | 1994-11-10 | The Green Cross Corporation | Nutritional transfusion for peripheral vein administration |
| JPH0920650A (en) * | 1995-07-03 | 1997-01-21 | Otsuka Pharmaceut Factory Inc | General infusion for peripheral vein administration |
| JP2004189677A (en) * | 2002-12-12 | 2004-07-08 | Otsuka Pharmaceut Factory Inc | Transfusion preparation |
| JP2007137836A (en) * | 2005-11-21 | 2007-06-07 | Ajinomoto Co Inc | Nutrition transfusion for peripheral vein |
| US20100143498A1 (en) * | 2007-05-25 | 2010-06-10 | Ajinomoto Co., Inc. | Infusion solution for peripheral intravenous administration |
| EP2647370A1 (en) * | 2010-11-29 | 2013-10-09 | Otsuka Pharmaceutical Factory, Inc. | Transfusion preparation |
-
2018
- 2018-01-09 GB GB1800318.6A patent/GB2569997A/en not_active Withdrawn
Patent Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO1994025059A1 (en) * | 1993-04-30 | 1994-11-10 | The Green Cross Corporation | Nutritional transfusion for peripheral vein administration |
| JPH0920650A (en) * | 1995-07-03 | 1997-01-21 | Otsuka Pharmaceut Factory Inc | General infusion for peripheral vein administration |
| JP2004189677A (en) * | 2002-12-12 | 2004-07-08 | Otsuka Pharmaceut Factory Inc | Transfusion preparation |
| JP2007137836A (en) * | 2005-11-21 | 2007-06-07 | Ajinomoto Co Inc | Nutrition transfusion for peripheral vein |
| US20100143498A1 (en) * | 2007-05-25 | 2010-06-10 | Ajinomoto Co., Inc. | Infusion solution for peripheral intravenous administration |
| EP2647370A1 (en) * | 2010-11-29 | 2013-10-09 | Otsuka Pharmaceutical Factory, Inc. | Transfusion preparation |
Non-Patent Citations (1)
| Title |
|---|
| Potassium Chloride in Dextrose and Sodium Chloride Injection, USP * |
Also Published As
| Publication number | Publication date |
|---|---|
| GB201800318D0 (en) | 2018-02-21 |
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