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

ICU-acquired Hypernatremia Clinical Trial

— BIAS  

Official title:

Balance Study on ICU-acquired Hypernatremia and Sodium Handling

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03093766
• Other study ID #: ZRTPO 996
• Status: Completed
• Start date: August 7, 2017
• Est. completion date: June 1, 2018

Study information

• Verified date: May 2017
• Source: Medical Centre Leeuwarden
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: June 1, 2018
• Est. primary completion date: April 16, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypernatremia
• ICU-acquired Hypernatremia

Locations

Country	Name	City	State
Netherlands	Medisch Centrum Leeuwarden	Leeuwarden

Sponsors (2)

Lead Sponsor	Collaborator
Medical Centre Leeuwarden	University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

References & Publications (3)

Bihari S, Ou J, Holt AW, Bersten AD. Inadvertent sodium loading in critically ill patients. Crit Care Resusc. 2012 Mar;14(1):33-7. — View 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. — View 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. Epub 2016 Sep 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sodium balance	Differences in sodium balances between patients who do and do not develop IAH	During ICU-admission
Primary	Fluid balance	Differences in fluid balances between patients who do and do not develop IAH	During ICU-admission
Secondary	Kidney function	Differences in parameters concerning kidney function (creatinine, urea) between patients who do and do not develop IAH	During ICU-admission
Secondary	Inflammation	Differences in inflammation (CRP, infections) between patients who do and do not develop IAH	During ICU-admission
Secondary	Nutritional state	Differences in nutritional state (albumin, BIVA-measurement) between patients who do and do not develop IAH	During ICU-admission