Prospective Analysis Into Development of Hypernatremia in Critically Ill Patients

Critical Illness Clinical Trial

— HYPNIC II  

Official title:

Development of Hypernatremia in Critically Ill Patients: Prospective Analysis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05085223
• Other study ID #: HYPNIC II
• Status: Not yet recruiting
• Start date: October 2021
• Est. completion date: November 30, 2022

Study information

• Verified date: October 2021
• Source: Catharina Ziekenhuis Eindhoven
• Contact: Eveline Mestrom, MD
• Phone: 0031402399500
• Email: eveline.mestrom[@]catharinaziekenhuis.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1500
• Est. completion date: November 30, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Age 17 years or younger

Related Conditions & MeSH terms

• Critical Illness
• Hypernatremia

Intervention

Other:
• Daily urine collection for biochemical analysis
For every patient in ICU, a daily morning urine sample will be collected from the already collected urine via catheter.
• Subanalysis for comparison of 24hour urine collection versus spot-check measurements
For a subgroup of 30 sedated patients, 24 hour urine collection will be collected. In addition, every 2 hours a 10ml urine sample will be collected.

Locations

Country	Name	City	State
Netherlands	Catharina Hospital Eindhoven	Eindhoven	Noord-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Catharina Ziekenhuis Eindhoven

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

Mestrom EHJ, van der Stam JA, Te Pas ME, van der Hoeven JG, van Riel NAW, Bindels AJGH, Boer A, Scharnhorst V. Increased sodium intake and decreased sodium excretion in ICU-acquired hypernatremia: A prospective cohort study. J Crit Care. 2021 Jun;63:68-75. doi: 10.1016/j.jcrc.2021.02.002. Epub 2021 Feb 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hypernatremia	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.	During admission in ICU
Secondary	24 hour urine replacement for spot-checks	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	24 hours