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Completed

NCT Number: NCT03093766

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medisch Centrum Leeuwarden

Leeuwarden, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Sodium balance

    Time frame: During ICU-admission

    Differences in sodium balances between patients who do and do not develop IAH

  2. Fluid balance

    Time frame: During ICU-admission

    Differences in fluid balances between patients who do and do not develop IAH

Secondary outcomes

  1. Kidney function

    Time frame: During ICU-admission

    Differences in parameters concerning kidney function (creatinine, urea) between patients who do and do not develop IAH

  2. Inflammation

    Time frame: During ICU-admission

    Differences in inflammation (CRP, infections) between patients who do and do not develop IAH

  3. Nutritional state

    Time frame: During ICU-admission

    Differences in nutritional state (albumin, BIVA-measurement) between patients who do and do not develop IAH

Sponsors and collaborators

Lead sponsor

Frisius Medisch Centrum

Other

Collaborators

  • University Medical Center Groningen

Registry information

Official study title

Balance Study on ICU-acquired Hypernatremia and Sodium Handling

Acronym: BIAS

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 28, 2017
Registry last updated
Jul 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.