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Hypernatraemia and diuretics

Conditions
Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
Intensive Care admissionsodium level in plasma > 142 mmol/L
Registration Number
EUCTR2013-002165-19-NL
Lead Sponsor
Medical Center Leeuwarden
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Authorised-recruitment may be ongoing or finished
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

admission in the intensive care
age > 18 years
sodium level in plasma > 142 mmol/L
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

sodium level > 142 mmol/L before admission
no informed consent
diabetes insipidus

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Main Objective: To establish whether captopril / hydrochloorthiazide is able to reduce hypernatraemia in intensive care patients;Secondary Objective: To establish whether captopril / hydrochloorthiazide is able to reduce the timperiod of hypernatraemia in intensive care patients;Primary end point(s): 5 points decrease of sodium level in plasma in mmol/L;Timepoint(s) of evaluation of this end point: 7 days
Secondary Outcome Measures
NameTimeMethod
Secondary end point(s): decrease of duration of hypernatraemia;Timepoint(s) of evaluation of this end point: 7 days
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