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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Observational

Official Title: Balance Study on ICU-acquired Hypernatremia and Sodium Handling

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 Summary: 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.
Sponsor: Medical Centre Leeuwarden

Current Primary Outcome:

  • Sodium balance [ Time Frame: During ICU-admission ]
    Differences in sodium balances between patients who do and do not develop IAH
  • Fluid balance [ Time Frame: During ICU-admission ]
    Differences in fluid balances between patients who do and do not develop IAH


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Medical Centre Leeuwarden

Dates:
Date Received: March 22, 2017
Date Started: May 1, 2017
Date Completion: December 1, 2017
Last Updated: April 19, 2017
Last Verified: March 2017