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Status unknownNCT05085223HYPNIC IIUpdated Oct 27, 2021

Prospective Analysis Into Development of Hypernatremia in Critically Ill Patients

An observational study in Hypernatremia and Critical Illness, sponsored by Catharina Ziekenhuis Eindhoven. Status unknown at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-27.

Sponsored by Catharina Ziekenhuis Eindhoven · Observational

The sponsor has not verified this record recently (last verified Oct 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,500
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Hypernatremia
  • Critical Illness
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

All patients admitted to the Intensive Care Unit.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Age 17 years or younger
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,500 participants (estimated)
Patient registry
No

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.

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: During admission in ICU

Secondary outcomes

  1. 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

    Time frame: 24 hours

06

Study locations

1 site
07

References and documents

Publications

  • 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. PubMed 33621892 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT05085223
Lead sponsor
Catharina Ziekenhuis Eindhoven
Responsible party
Eveline Mestrom (Principal Investigator, Catharina Ziekenhuis Eindhoven) — Principal investigator
First posted
Oct 20, 2021
Start date
Oct 2021 (estimated)
Primary completion
Oct 31, 2022 (estimated)
Completion
Nov 30, 2022 (estimated)
Last update
Oct 27, 2021

Study contacts

Eveline Mestrom, MD
Contact
eveline.mestrom@catharinaziekenhuis.nl
0031402399500
Jonna van der Stam, MSc
Contact
Jonna.vd.stam@catharinaziekenhuis.nl
0031402398675

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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