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

April 27, 2019 updated by: André Luiz Nunes Gobatto, University of Sao Paulo

Safety and Efficacy of Hydrochlorothiazide in the Treatment of Hypernatremia in Critically Ill Patients: a Randomized Controlled Trial

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

Study Overview

Status

Unknown

Study Type

Interventional

Enrollment (Anticipated)

184

Phase

  • Phase 2

Contacts and Locations

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

Study Contact

Study Locations

      • São Paulo, Brazil
        • Recruiting
        • Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
        • Contact:
        • Principal Investigator:
          • André LN Gobatto, M.D.

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intervention
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.
for the experimental group received a hydrochlorothiazide tablet on presentation of 50mg or equivalent enteral solution every 12h (total of 100mg per day) enterally on day 0 (D0) until day 3
Placebo Comparator: Control
placebo group will receive one tablet or equivalent volume of enteral solution of inert substance
for the placebo group will receive one tablet or equivalent volume of enteral solution of inert substance, identical to the hydrochlorothiazide presentations, every 12 hours until day 3

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hypernatremia correction
Time Frame: DAY 3
proportion of patients with hypernatremia correction (serum sodium below 145 mEq / L) at the end of Day 3
DAY 3

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
renal replacement therapy
Time Frame: 6 months
need to renal replacement therapy
6 months
mechanical ventilation
Time Frame: 6 months
incidence of mechanical ventilation
6 months
vasoactive drugs
Time Frame: 6 months
need for vasoactive drugs
6 months
mortality
Time Frame: 6 months
hospital mortality
6 months
serious adverse events
Time Frame: 6 months
incidence of serious adverse events 37/5000 incidence of serious adverse events
6 months

Collaborators and Investigators

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

Investigators

  • Principal Investigator: André LN Gobatto, p.h.d, University of Sao Paulo

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 (Actual)

October 1, 2018

Primary Completion (Anticipated)

December 10, 2019

Study Completion (Anticipated)

March 10, 2020

Study Registration Dates

First Submitted

May 22, 2018

First Submitted That Met QC Criteria

September 3, 2018

First Posted (Actual)

September 5, 2018

Study Record Updates

Last Update Posted (Actual)

April 30, 2019

Last Update Submitted That Met QC Criteria

April 27, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

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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