Hydrochloorthiazide and Hypernatriaemie

June 22, 2015 updated by: E.C. Boerma, Medical Centre Leeuwarden

Hypernatraemia and Diuretics in Intensive Care Patients

Acquired hypernatremia appears to be associated with mortallity in ICU. To reduce hypernatremia and shorten the time of hypernatremia, we investigate the effect of hydrochloorthiazide compared to a placebo

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Netherlands
    • Friesland
      • Leeuwarden, Friesland, Netherlands, 8801 AD
        • Medical Centre Leeuwarden

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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • sodium > 142

Exclusion Criteria:

  • no informed consent

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: hydrochloorthiazide
once a day 25 mg
Drug: Hydrochloorthiazide
Placebo Comparator: placebo
once a day placebo
Drug: placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sodium level
Time Frame: 7 days
a decrease of 5 mmol/L sodium in plama
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time hypernatraemia
Time Frame: 7 days
decrease of duration high sodium level in plasma
7 days

Collaborators and Investigators

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

Sponsor

Medical Centre Leeuwarden

Investigators

  • Principal Investigator: Christiaan Boerma, MD, Medical Centre Leeuwarden

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

September 1, 2013

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

October 28, 2013

First Submitted That Met QC Criteria

October 28, 2013

First Posted (Estimate)

November 3, 2013

Study Record Updates

Last Update Posted (Estimate)

June 23, 2015

Last Update Submitted That Met QC Criteria

June 22, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABR 44878

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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