Plasma Sodium and Sodium Administration in the ICU

NCT06037928 | Unknown

• 1 other identifier: IVA-salt
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypernatremia; Hyponatremia; Critical Illness

Keywords

Fluid Therapy; ICU; Drug Prescription

Outcome Measures

Primary Outcomes (1)

• 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.

  During admission to ICU for a maximum of 28 days

Secondary Outcomes (6)

• 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.

  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.

  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.

  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.

  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.

  During admission to ICU for a maximum of 28 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Critically ill patients with a documented length of stay at the Intensive Care Unit of seven days minimum

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Linkoeping: lead

Study Sites (1)

University Hospital Linköping

Linköping, 58185, Sweden

RECRUITING

Related Publications (3)

• 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.

  PMID: 33826113 BACKGROUND

• 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.

  PMID: 25586725 BACKGROUND

• 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.

  PMID: 33999276 BACKGROUND

MeSH Terms

Conditions

Hypernatremia; Hyponatremia; Critical Illness

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Hans Bahlmann, MD, PhD

CONTACT

+46739312281; hans.bahlmann@regionostergotland.se

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sponsor

Study Record Dates

• First Submitted: September 7, 2023
• First Posted: September 14, 2023
• Study Start: September 4, 2023
• Primary Completion: November 30, 2023
• Study Completion: January 31, 2024
• Last Updated: September 26, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)