Prospective Analysis Into Development of Hypernatremia in Critically Ill Patients

NCT05085223 | Unknown

• 1 other identifier: HYPNIC II
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypernatremia; Critical Illness

Outcome Measures

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.

  During admission in ICU

Secondary Outcomes (1)

• 24 hour urine replacement for spot-checks

  24 hours

Interventions

Daily urine collection for biochemical analysis OTHER

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 OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients admitted to the Intensive Care Unit.

You may qualify if:

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

You may not qualify if:

• Age 17 years or younger

Sponsors & Collaborators

• Catharina Ziekenhuis Eindhoven: lead

Study Sites (1)

Catharina Hospital Eindhoven

Eindhoven, North Brabant, 5623 EJ, Netherlands

Location

Related 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.

  PMID: 33621892 BACKGROUND

MeSH Terms

Conditions

Hypernatremia; Critical Illness

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Eveline Mestrom, MD

CONTACT

0031402399500; eveline.mestrom@catharinaziekenhuis.nl

Jonna van der Stam, MSc

CONTACT

0031402398675; Jonna.vd.stam@catharinaziekenhuis.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 7, 2021
• First Posted: October 20, 2021
• Study Start: October 1, 2021
• Primary Completion: October 31, 2022
• Study Completion: November 30, 2022
• Last Updated: October 27, 2021

Record last verified: 2021-10

Locations

NL (1)