Safety and Efficacy of Hydrochlorothiazide in the Treatment of Hypernatremia in Critically Ill Patients

Phase 2

• Conditions: Critical Illness; Hypernatremia
• Interventions: Drug: Hydrochlorothiazide 50Mg; Drug: Placebos

• Registration Number: NCT03658850
• Lead Sponsor: University of Sao Paulo

Brief Summary

HYDRA is a randomized clinical trial designed to evaluate safety and efficiency of hydrochlorothiazide in critical patients with hypernatremia

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-22
• Study First Submitted QC: 2018-09-03
• Study First Posted: 2018-09-05
• Study Start: 2018-10-01
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-27
• Last Update Posted: 2019-04-30
• Primary Completion: 2019-12-10
• Study Completion: 2020-03-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 184

Inclusion Criteria

• hospitalized for intensive care,
• Over 18 years of age,
• Two serum sodium measurements above 145 mEq / L (with no pre-determined interval between them),
• Mean arterial pressure greater than 65mmHg

Exclusion Criteria

• Absence of consent to participate in the study
• Cardiac index below 2.5L / min / m2 OR signs of ineffective circulation (capillary filling time greater than 2 seconds, cold or sticky skin) OR arterial lactate> 4mMol / L.
• Use of vasopressors at doses greater than 0.1 mcg / kg / min of noradrenaline or with initiation or increase of dose within less than one hour before inclusion in the study.
• Unavailable enteral route.
• Use of hydrochlorothiazide in the last 7 days of ICU admission.
• History of allergy or intolerance to hydrochlorothiazide or other thiazides.
• Nephrogenic Diabetes Insipidus.
• Renal impairment KDIGO 3
• Indication of renal replacement therapy.
• Acute neurological insult.
• Heart failure American Heart Association classification (AHA), class D.
• Liver cirrhosis Child-Pugh C.
• Pregnant women
• Exclusive palliative care
• Dying, with expected survival less than 48 hours

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Hydrochlorothiazide 50Mg	the experimental group will receive one tablet of hydrochlorothiazide in the presentation of 50mg or equivalent enteral solution every 12h (total of 100mg per day) enterally for 3 days.
Control	Placebos	placebo group will receive one tablet or equivalent volume of enteral solution of inert substance

Primary Outcome Measures

Name	Time	Method
hypernatremia correction	DAY 3	proportion of patients with hypernatremia correction (serum sodium below 145 mEq / L) at the end of Day 3

Secondary Outcome Measures

Name	Time	Method
renal replacement therapy	6 months	need to renal replacement therapy
mechanical ventilation	6 months	incidence of mechanical ventilation
mortality	6 months	hospital mortality
vasoactive drugs	6 months	need for vasoactive drugs
serious adverse events	6 months	incidence of serious adverse events 37/5000 incidence of serious adverse events

Trial Locations

Locations (1)

Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo; 🇧🇷 São Paulo, Brazil