Clinical trial NCT03093766: Balance Study on ICU-acquired Hypernatremia and Sodium Handling (BIAS)
Official title: Balance Study on ICU-acquired Hypernatremia and Sodium Handling
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ICU-acquired Hypernatremia
Keywords: Aetiology
Lead sponsor: Frisius Medisch Centrum
Sponsor class: OTHER
Collaborators: name: University Medical Center Groningen
First posted: 2017-03-28
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All unplanned ICU-admissions

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.

Eligibility criteria: 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

Primary outcomes:
measure: Sodium balance
timeFrame: During ICU-admission
measure: Fluid balance
timeFrame: During ICU-admission
Secondary outcomes:
measure: Kidney function
timeFrame: During ICU-admission
measure: Inflammation
timeFrame: During ICU-admission
measure: Nutritional state
timeFrame: During ICU-admission
Other outcomes:
Locations:
city: Leeuwarden
country: Netherlands
facility: Medisch Centrum Leeuwarden
Study officials:
affiliation: medical center leeuwarden
name: Christiaan Boerma
role: PRINCIPAL_INVESTIGATOR
References:
citation: Darmon M, Diconne E, Souweine B, Ruckly S, Adrie C, Azoulay E, Clec'h C, Garrouste-Orgeas M, Schwebel C, Goldgran-Toledano D, Khallel H, Dumenil AS, Jamali S, Cheval C, Allaouchiche B, Zeni F, Timsit JF. Prognostic consequences of borderline dysnatremia: pay attention to minimal serum sodium change. Crit Care. 2013 Jan 21;17(1):R12. doi: 10.1186/cc11937.
citation: van IJzendoorn MC, Buter H, Kingma WP, Navis GJ, Boerma EC. The Development of Intensive Care Unit Acquired Hypernatremia Is Not Explained by Sodium Overload or Water Deficit: A Retrospective Cohort Study on Water Balance and Sodium Handling. Crit Care Res Pract. 2016;2016:9571583. doi: 10.1155/2016/9571583. Epub 2016 Sep 14.
citation: Bihari S, Ou J, Holt AW, Bersten AD. Inadvertent sodium loading in critically ill patients. Crit Care Resusc. 2012 Mar;14(1):33-7.