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

Balance Study on ICU-acquired Hypernatremia and Sodium Handling

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.

Study Overview

• Status: Completed
• Conditions: ICU-acquired Hypernatremia

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 Type: Observational
• Enrollment (Actual): 155

Contacts and Locations

Study Locations

• Netherlands
  • Leeuwarden, Netherlands
    • Medisch Centrum Leeuwarden

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All unplanned ICU-admissions

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sodium balance	Differences in sodium balances between patients who do and do not develop IAH	During ICU-admission
Fluid balance	Differences in fluid balances between patients who do and do not develop IAH	During ICU-admission

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Medical Centre Leeuwarden
• Collaborators: University Medical Center Groningen
• Investigators: Principal Investigator: Christiaan Boerma, Medical Center Leeuwarden

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 7, 2017
• Primary Completion (ACTUAL): April 16, 2018
• Study Completion (ACTUAL): June 1, 2018

Study Registration Dates

• First Submitted: March 22, 2017
• First Submitted That Met QC Criteria: March 27, 2017
• First Posted (ACTUAL): March 28, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 18, 2018
• Last Update Submitted That Met QC Criteria: July 17, 2018
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Aetiology
• Additional Relevant MeSH Terms: Metabolic Diseases; Water-Electrolyte Imbalance; Hypernatremia
• Other Study ID Numbers: ZRTPO 996

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Collected data will be available through an online portal / storage website as soon as the manuscript was published. From that moment data can be obtained after a request via the online portal / storage website.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No