Prospective Analysis Into Development of Hypernatremia in Critically Ill Patients (HYPNIC II)

October 20, 2021 updated by: Eveline Mestrom, Catharina Ziekenhuis Eindhoven

Development of Hypernatremia in Critically Ill Patients: Prospective Analysis

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Eveline Mestrom, MD
Phone Number: 0031402399500
Email: eveline.mestrom@catharinaziekenhuis.nl

Study Contact Backup

Name: Jonna van der Stam, MSc
Phone Number: 0031402398675
Email: Jonna.vd.stam@catharinaziekenhuis.nl

Study Locations

Netherlands
- Noord-Brabant
  - Eindhoven, Noord-Brabant, Netherlands, 5623 EJ
    - Catharina Hospital Eindhoven
    - Contact:
      
      Eveline Mestrom, MD
      
      Phone Number: 0031402399500
      
      Email: eveline.mestrom@catharinaziekenhuis.nl
    - Contact:
      
      Ashley de Bie, MD, PhD
      
      Phone Number: 0031402399500
      
      Email: ashley.d.bie@catharinaziekenhuis.nl
    - Principal Investigator:
      
      Jonna van der Stam, M.Sc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All patients admitted to the Intensive Care Unit.

Description

Inclusion Criteria:

Admitted to Intensive Care Unit
Age 18 years or older

Exclusion Criteria:

Age 17 years or younger

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Cohort
Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hypernatremia Time Frame: During admission in ICU	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
24 hour urine replacement for spot-checks Time Frame: 24 hours	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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Catharina Ziekenhuis Eindhoven

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2021

Primary Completion (Anticipated)

October 31, 2022

Study Completion (Anticipated)

November 30, 2022

Study Registration Dates

First Submitted

October 7, 2021

First Submitted That Met QC Criteria