An observational study in Hypernatremia, Hyponatremia and Critical Illness, sponsored by University Hospital, Linkoeping. Recruiting at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-26.
Sponsored by University Hospital, Linkoeping · Observational
Patients in the Intensive Care Unit often present with low levels of plasma sodium and are therefore often administered high amounts of sodium, both as an additive to intravenous glucose solutions and as a constituent of various drugs and infusion fluids. Recent findings question the benefit of these large quantities of sodium and raise the question whether the individual physician takes the total sodium administration into account when sodium additives are prescribed. It can also be suspected that sodium prescription differs significantly between physicians.
Treatment with intravenous fluids (fluid therapy) is a cornerstone in intensive care. The primary aim of fluid therapy is to optimize the amount of fluid in the various spaces of the body: intravascularly (plasma), intracellularly and interstitially. Secondarily, one tries to optimize the constitution of fluid in plasma, since this is the only fluid space that is available for analysis. Fluid constitution is referring to the physical properties such as pH-value, osmolality, and partly the concentration of different elements solved in plasma (i.e. sodium, potassium, chloride, magnesium, and proteins like albumin). For this reason, there are a lot of different fluids that the physician in the intensive care can choose from. In addition, the physician can also choose to prescribe different additives to adapt these fluids to fulfil the individual patient's needs. Therefore, to prescribe both the amount and constituency of fluid therapy is a key task for ICU-physicians.
One of the most important additives to be prescribed is sodium. Sodium is the molecule (except for water) that has the highest concentration in plasma (normally around 140 mmol/L) and is therefore of utmost importance for plasma osmolality. Sodium concentration in plasma is often decreased in critically ill patients (hyponatremia) which, in turn, is associated with a worse outcome, and thus a normal task for an ICU-physician to attempt to regulate through administering amounts of sodium that are substantially higher than the physiological needs.
Recent findings have revealed that there is a large variation between different physicians when it comes to the amount of fluid the patient receives, a variation that has no scientific basis.
Fluids used in the operating room and in the intensive care often contain large quantities of sodium to create a physiological osmolality. It is thus hypothesized that it is not only the large quantities of fluid that causes a worse outcome in fluid overload, but also the un-physiologically large amount of administered sodium.
The aim of the study is partly to gain knowledge about how sodium prescription is performed in clinical practice in the intensive care, as well as how this administration relates to actual changes in plasma sodium.
Statistical method: Normal distribution will be tested via the Shapiro-Wilks test. All tests of significance are performed two-sided. P-value lower than 0.05 is considered significant. No corrections for multiple comparisons are performed if nothing else is stated.
Missing values: Single missing values are principally not replaced. In exceptional cases, if missing data leads to a whole series of data being misleading, then missing data can be imputed by calculating the mean of two adjacent values, under the condition that this results in a reasonable value.
49 studies on the registry are indexed under Hypernatremia; 8 are open to participants now.
This study's planned enrollment of 200 is close to the median of 200 across 12 observational studies indexed under Hypernatremia.
Browse Hypernatremia studies →University Hospital, Linkoeping is the lead sponsor of 119 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Critically ill patients with a documented length of stay at the Intensive Care Unit of seven days minimum
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The coefficient of determination (r2) between the amount prescribed sodium additive and the amount of sodium the patient is expected to receive through other routes.
The amount of sodium additive is defined as the amount of sodium in mmol/kg ABW (actual body weight) that is being given in glucose solutions during the coming 24 hours. Example: A patient weighing 70 kilograms is being prescribed intravenous glucose of 1L, with an additive of 40 mmol of sodium during 12 hours. The amount of additive will then be calculated as (40+40)×2⁄70=2.3 mmol/kg The amount of expected sodium administrated, per kg and day, is defined as the sodium contents of: 1. Enteral and/or parenteral nutrition during one day. 2. Drugs administered through infusion pumps during one day. 3. Other fluids that have been prescribed during the morning round.
Time frame: During admission to ICU for a maximum of 28 days
The coefficient of determination (r2) in a multivariate analysis where prescribing physician is the independent variable and the amount of prescribed sodium additive is the dependent variable.
Only data points where administering physician has been registered and where plasma sodium is \< 150 mmol/L are included. Data will, however, be displayed for all levels of plasma sodium. The amount of sodium additive is defined as the amount of sodium in mmol/kg ABW that is prescribed through glucose infusion the coming day.
Time frame: During admission to ICU for a maximum of 28 days
Difference in median or mean in the amount of prescribed sodium additive between anesthesiologists mainly working in intensive care, anesthesiologists mainly working with patients undergoing surgery and between resident physicians.
Only data points where administering physician has been registered and where plasma sodium is \< 150 mmol/L are included. Data will, however, be displayed for all levels of plasma sodium. Information regarding chief working area will be retrieved through the schedule of the clinic.
Time frame: During admission to ICU for a maximum of 28 days
Difference in median or mean in the amount of prescribed sodium additive between physicians born no later than 12-31-1982 and physicians born 1983 and later.
Only data points where administering physician has been registered and where plasma sodium is \< 150 mmol/L are included. Data will, however, be displayed for all levels of plasma sodium. Information regarding birth year is retrieved through an official database (www.mrkoll.se).
Time frame: During admission to ICU for a maximum of 28 days
The coefficient of determination (r2) between plasma sodium and the amount of prescribed sodium additive.
Only data points where plasma sodium is \< 150 mmol/L are included. Data will, however, be displayed for all levels of plasma sodium.
Time frame: During admission to ICU for a maximum of 28 days
The coefficient of determination (r2) between the amount of prescribed sodium additive and observed changes in plasma sodium.
Calculated in intervals of 1, 2, 3, 4 and 5 days
Time frame: During admission to ICU for a maximum of 28 days
The coefficient of determination (r2) between the total amount of administered sodium and observed changes in plasma sodium.
Calculated in intervals of 1, 2, 3, 4 and 5 days
Time frame: During admission to ICU for a maximum of 28 days
Plan to share: No
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