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Hydrochloorthiazide and Hypernatriaemie

Primary Purpose

Hypernatraemia

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Hydrochloorthiazide
placebo
Sponsored by
Medical Centre Leeuwarden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypernatraemia focused on measuring intensive care, diuretics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • sodium > 142

Exclusion Criteria:

  • no informed consent

Sites / Locations

  • Medical Centre Leeuwarden

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

hydrochloorthiazide

placebo

Arm Description

once a day 25 mg

once a day placebo

Outcomes

Primary Outcome Measures

sodium level
a decrease of 5 mmol/L sodium in plama

Secondary Outcome Measures

time hypernatraemia
decrease of duration high sodium level in plasma

Full Information

First Posted
October 28, 2013
Last Updated
June 22, 2015
Sponsor
Medical Centre Leeuwarden
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1. Study Identification

Unique Protocol Identification Number
NCT01974739
Brief Title
Hydrochloorthiazide and Hypernatriaemie
Official Title
Hypernatraemia and Diuretics in Intensive Care Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical Centre Leeuwarden

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypernatraemia
Keywords
intensive care, diuretics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
hydrochloorthiazide
Arm Type
Active Comparator
Arm Description
once a day 25 mg
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
once a day placebo
Intervention Type
Drug
Intervention Name(s)
Hydrochloorthiazide
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
sodium level
Description
a decrease of 5 mmol/L sodium in plama
Time Frame
7 days
Secondary Outcome Measure Information:
Title
time hypernatraemia
Description
decrease of duration high sodium level in plasma
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: sodium > 142 Exclusion Criteria: no informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christiaan Boerma, MD
Organizational Affiliation
Medical Centre Leeuwarden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Centre Leeuwarden
City
Leeuwarden
State/Province
Friesland
ZIP/Postal Code
8801 AD
Country
Netherlands

12. IPD Sharing Statement

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Hydrochloorthiazide and Hypernatriaemie

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