- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03658850
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
Conditions
Intervention / Treatment
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
- Name: André LN Gobatto, p.h.d
- Phone Number: +5571988646501
- Email: andregobatto@gmail.com
Study Locations
-
-
-
São Paulo, Brazil
- Recruiting
- Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
-
Contact:
- André LN Gobatto, M.D.
- Phone Number: +5511991796501
- Email: andregobatto@gmail.com
-
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.
Sponsor
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
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Metabolic Diseases
- Disease Attributes
- Water-Electrolyte Imbalance
- Critical Illness
- Hypernatremia
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Natriuretic Agents
- Membrane Transport Modulators
- Diuretics
- Sodium Chloride Symporter Inhibitors
- Hydrochlorothiazide
Other Study ID Numbers
- 2.603.927
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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