Prospective Analysis Into Development of Hypernatremia in Critically Ill Patients

• Conditions: Hypernatremia; Critical Illness

• Registration Number: NCT05085223
• Lead Sponsor: Catharina Ziekenhuis Eindhoven

Brief Summary

Hypernatremia is frequently encountered in patients admitted to the Intensive Care Unit (ICU) and associated with increased mortality and length of stay. Previous studies focused on predictors in the development and recovery of hypernatremia by including amount and types of administered medication, fluid balance, laboratory results and changes in vital signs. However, data of larger populations or data on infusion rates, fluid and sodium balance or renal replacement therapy is lacking. The predecessor of this study was the HYPNIC trial which found that increased sodium load en decreased sodium excretion preceded hypernatremia development, but was lacking information on the first 48 hours, fluid balances were manually collected before a new data collection system was introduced and was suffering from substantial amounts of missing data and small population for trend analysis.

This study aims to provide better insight in the development and recovery of hypernatremia while paying attention to the limitations from the HYPNIC trial.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-10
• Study Start: 2021-10
• Study First Submitted: 2021-10-07
• Study First Submitted QC: 2021-10-07
• Study First Posted: 2021-10-20
• Last Update Submitted: 2021-10-20
• Last Update Posted: 2021-10-27
• Primary Completion: 2022-10-31
• Study Completion: 2022-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

• Admitted to Intensive Care Unit
• Age 18 years or older

Exclusion Criteria

• Age 17 years or younger

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hypernatremia	During admission in ICU	After one year of collecting data on fluid and sodium balances, the patients who developed hypernatremia during their admission in the Intensive Care Unit will be compared to the patients who remained normonatremic throughout their ICU admission.

Secondary Outcome Measures

Name	Time	Method
24 hour urine replacement for spot-checks	24 hours	Assessing whether 24 hour urine collection can be replaced by spot-check measurements of urine by comparing both 24 hour urine and 2 hourly urine samples

Trial Locations

Locations (1)

Catharina Hospital Eindhoven; 🇳🇱 Eindhoven, Noord-Brabant, Netherlands