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Prospective Analysis Into Development of Hypernatremia in Critically Ill Patients

NCT ID: NCT05085223

Last Updated: 2021-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-31

Study Completion Date

2022-11-30

Brief Summary

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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

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Conditions

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Hypernatremia Critical Illness

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Age 17 years or younger
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Catharina Ziekenhuis Eindhoven

OTHER

Sponsor Role lead

Responsible Party

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Eveline Mestrom

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Catharina Hospital Eindhoven

Eindhoven, North Brabant, Netherlands

Site Status

Countries

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Netherlands

Central Contacts

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Eveline Mestrom, MD

Role: CONTACT

Phone: 0031402399500

Email: [email protected]

Jonna van der Stam, MSc

Role: CONTACT

Phone: 0031402398675

Email: [email protected]

Facility Contacts

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Eveline Mestrom, MD

Role: primary

Ashley de Bie, MD, PhD

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 33621892 (View on PubMed)

Other Identifiers

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HYPNIC II

Identifier Type: -

Identifier Source: org_study_id