Balance Study on ICU-acquired Hypernatremia and Sodium Handling (BIAS)

Completed

• Conditions: ICU-acquired Hypernatremia

• Registration Number: NCT03093766
• Lead Sponsor: Medical Centre Leeuwarden

Brief Summary

The goal of this study is to find differences between patients who do and do not develop ICU-acquired hypernatremia (IAH). Therefore extended sodium and fluid balances will be performed. Also a couple of other factors that possibly contribute to the development of IAH and/or could give clues about the mechanisms in the development of IAH will be investigated.

Detailed Description

ICU-acquired hypernatremia (IAH) is common in critically ill patients, but it's aetiology is still not fully understood. Sodium overload and inadequate fluid administration are generally considered important factors, but a previous retrospective study did not reveal differences in sodium or fluid balances between patients who did and did not develop IAH. Because this was retrospective these balances will be prospectively studied in this study to be more sure about the importances of these balances in the development of IAH. Previous studies indicated that (a lot) more factors contribute to the development of IAH. In this study these factors will be investigated, hoping to find differences between patients who do and do not develop IAH.

Study Timeline

• Study First Submitted: 2017-03-22
• Study First Submitted QC: 2017-03-27
• Study First Posted: 2017-03-28
• Status Verified: 2017-05
• Study Start: 2017-08-07
• Primary Completion: 2018-04-16
• Study Completion: 2018-06-01
• Last Update Submitted: 2018-07-17
• Last Update Posted: 2018-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 155

Inclusion Criteria

• Predicted duration of ICU-admission >48 hours

Exclusion Criteria

• Renal replacement therapy
• Reason for admission necessitates actively elevation of serum sodium concentration
• Electrolyte disturbance as reason for admission
• ICU re-admission within 30 days
• Referral from another ICU
• Serum sodium concentration on admission 143mmol/l or above

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sodium balance	During ICU-admission	Differences in sodium balances between patients who do and do not develop IAH
Fluid balance	During ICU-admission	Differences in fluid balances between patients who do and do not develop IAH

Secondary Outcome Measures

Name	Time	Method
Kidney function	During ICU-admission	Differences in parameters concerning kidney function (creatinine, urea) between patients who do and do not develop IAH
Inflammation	During ICU-admission	Differences in inflammation (CRP, infections) between patients who do and do not develop IAH
Nutritional state	During ICU-admission	Differences in nutritional state (albumin, BIVA-measurement) between patients who do and do not develop IAH

Trial Locations

Locations (1)

Medisch Centrum Leeuwarden; 🇳🇱 Leeuwarden, Netherlands