Critical Illness Clinical Trial
Official title:
Plasma Sodium and Sodium Administration in the ICU. A Retrospective Observational Study.
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.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | January 31, 2024 |
Est. primary completion date | November 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Adult - Documented length of stay at the Central Intensive Care Unit (CIVA) at the University Hospital of Linköping of seven (7) days minimum. - The patient has been discharged from the ICU. - Body Mass Index (BMI) between 18.0 and 48.0 kg/m2 at admission. Exclusion Criteria: - The patient has previously been included in the study in connection with another ICU-admission. - The patient has a severe hyponatremia (<129 mmol/L) upon arrival to the ICU. - The patient has a severe hypernatremia (>149 mmol/L) upon arrival to the ICU. - The patient is severely hyperosmolar (>330 mmol/L) upon arrival to the ICU. - The patient is severely hyperglycemic (>30 mmol/L) upon arrival to the ICU. - The patient has an elevated serum urea (>30 mmol/L) upon arrival to the ICU. - The patient receives any dialysis treatment during the observation time. - The patient is suspected to have an elevated intracranial pressure during the observation time or is suspected to have other intracranial pathology that is likely to affect sodium homeostasis - The patient has an intoxication with toxic alcohols as a primary diagnosis. |
Country | Name | City | State |
---|---|---|---|
Sweden | University Hospital Linköping | Linköping |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Linkoeping |
Sweden,
De Carvalho H, Letellier T, Karakachoff M, Desvaux G, Caillon H, Papuchon E, Bentoumi-Loaec M, Benaouicha N, Canet E, Chapelet G, Le Turnier P, Montassier E, Rouhani A, Goffinet N, Figueres L. Hyponatremia is associated with poor outcome in COVID-19. J Nephrol. 2021 Aug;34(4):991-998. doi: 10.1007/s40620-021-01036-8. Epub 2021 Apr 7. — View Citation
Lilot M, Ehrenfeld JM, Lee C, Harrington B, Cannesson M, Rinehart J. Variability in practice and factors predictive of total crystalloid administration during abdominal surgery: retrospective two-centre analysis. Br J Anaesth. 2015 May;114(5):767-76. doi: 10.1093/bja/aeu452. Epub 2015 Jan 13. — View Citation
Van Regenmortel N, Moers L, Langer T, Roelant E, De Weerdt T, Caironi P, Malbrain MLNG, Elbers P, Van den Wyngaert T, Jorens PG. Fluid-induced harm in the hospital: look beyond volume and start considering sodium. From physiology towards recommendations for daily practice in hospitalized adults. Ann Intensive Care. 2021 May 17;11(1):79. doi: 10.1186/s13613-021-00851-3. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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: Enteral and/or parenteral nutrition during one day. Drugs administered through infusion pumps during one day. Other fluids that have been prescribed during the morning round. |
During admission to ICU for a maximum of 28 days | |
Secondary | 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. | During admission to ICU for a maximum of 28 days | |
Secondary | 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. | During admission to ICU for a maximum of 28 days | |
Secondary | 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). | During admission to ICU for a maximum of 28 days | |
Secondary | 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. | During admission to ICU for a maximum of 28 days | |
Secondary | 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 | During admission to ICU for a maximum of 28 days | |
Secondary | 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 | During admission to ICU for a maximum of 28 days |
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