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Prospective Analysis Into Development of Hypernatremia in Critically Ill Patients

Development of Hypernatremia in Critically Ill Patients: Prospective Analysis

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05085223
Acronym
HYPNIC II
Enrollment
1500
Registered
2021-10-20
Start date
2021-10-31
Completion date
2022-11-30
Last updated
2021-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness, Hypernatremia

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.

Interventions

OTHERDaily 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.

OTHERSubanalysis 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.

Sponsors

Catharina Ziekenhuis Eindhoven
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Age 17 years or younger

Design outcomes

Primary

MeasureTime frameDescription
HypernatremiaDuring admission in ICUAfter 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

MeasureTime frameDescription
24 hour urine replacement for spot-checks24 hoursAssessing 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

Countries

Netherlands

Contacts

Primary ContactEveline Mestrom, MD
eveline.mestrom@catharinaziekenhuis.nl0031402399500
Backup ContactJonna van der Stam, MSc
Jonna.vd.stam@catharinaziekenhuis.nl0031402398675

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026