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Clinical Trials/NCT05085223
NCT05085223
Unknown
Not Applicable

Development of Hypernatremia in Critically Ill Patients: Prospective Analysis

Catharina Ziekenhuis Eindhoven1 site in 1 country1,500 target enrollmentOctober 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypernatremia
Sponsor
Catharina Ziekenhuis Eindhoven
Enrollment
1500
Locations
1
Primary Endpoint
Hypernatremia
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2021
End Date
November 30, 2022
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Catharina Ziekenhuis Eindhoven
Responsible Party
Principal Investigator
Principal Investigator

Eveline Mestrom

Principal Investigator

Catharina Ziekenhuis Eindhoven

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Age 17 years or younger

Outcomes

Primary Outcomes

Hypernatremia

Time Frame: 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 Outcomes

  • 24 hour urine replacement for spot-checks(24 hours)

Study Sites (1)

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