Hydrochloorthiazide and Hypernatriaemie

Hypernatraemia Clinical Trial

Official title:

Hypernatraemia and Diuretics in Intensive Care Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01974739
• Other study ID #: ABR 44878
• Status: Completed
• Phase: N/A
• First received: October 28, 2013
• Last updated: June 22, 2015
• Start date: September 2013
• Est. completion date: May 2015

Study information

• Verified date: June 2015
• Source: Medical Centre Leeuwarden
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• sodium > 142

Exclusion Criteria:

• no informed consent

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypernatraemia
• Hypernatremia

Intervention

Drug:
• Hydrochloorthiazide

• placebo

Locations

Country	Name	City	State
Netherlands	Medical Centre Leeuwarden	Leeuwarden	Friesland

Sponsors (1)

Lead Sponsor	Collaborator
Medical Centre Leeuwarden

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sodium level	a decrease of 5 mmol/L sodium in plama	7 days	Yes
Secondary	time hypernatraemia	decrease of duration high sodium level in plasma	7 days	No