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Trial record 24 of 443 for:    Hydrochlorothiazide

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

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ClinicalTrials.gov Identifier: NCT03658850
Recruitment Status : Recruiting
First Posted : September 5, 2018
Last Update Posted : April 30, 2019
Sponsor:
Information provided by (Responsible Party):
André Luiz Nunes Gobatto, 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

Condition or disease Intervention/treatment Phase
Hypernatremia Critical Illness Drug: Hydrochlorothiazide 50Mg Drug: Placebos Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 184 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Hydrochlorothiazide in the Treatment of Hypernatremia in Critically Ill Patients: a Randomized Controlled Trial
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : December 10, 2019
Estimated Study Completion Date : March 10, 2020

Resource links provided by the National Library of Medicine


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.
Drug: Hydrochlorothiazide 50Mg
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
Drug: Placebos
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




Primary Outcome Measures :
  1. hypernatremia correction [ Time Frame: DAY 3 ]
    proportion of patients with hypernatremia correction (serum sodium below 145 mEq / L) at the end of Day 3


Secondary Outcome Measures :
  1. renal replacement therapy [ Time Frame: 6 months ]
    need to renal replacement therapy

  2. mechanical ventilation [ Time Frame: 6 months ]
    incidence of mechanical ventilation

  3. vasoactive drugs [ Time Frame: 6 months ]
    need for vasoactive drugs

  4. mortality [ Time Frame: 6 months ]
    hospital mortality

  5. serious adverse events [ Time Frame: 6 months ]
    incidence of serious adverse events 37/5000 incidence of serious adverse events



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03658850


Contacts
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Contact: André LN Gobatto, p.h.d +5571988646501 andregobatto@gmail.com

Locations
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Brazil
Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo Recruiting
São Paulo, Brazil
Contact: André LN Gobatto, M.D.    +5511991796501    andregobatto@gmail.com   
Principal Investigator: André LN Gobatto, M.D.         
Sponsors and Collaborators
University of Sao Paulo
Investigators
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Principal Investigator: André LN Gobatto, p.h.d University of Sao Paulo

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Responsible Party: André Luiz Nunes Gobatto, Principal Investigator, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT03658850     History of Changes
Other Study ID Numbers: 2.603.927
First Posted: September 5, 2018    Key Record Dates
Last Update Posted: April 30, 2019
Last Verified: April 2019

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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
Keywords provided by André Luiz Nunes Gobatto, University of Sao Paulo:
hypernatremia
Critical care
Additional relevant MeSH terms:
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Hydrochlorothiazide
Hypernatremia
Critical Illness
Disease Attributes
Pathologic Processes
Water-Electrolyte Imbalance
Metabolic Diseases
Pharmaceutical Solutions
Antihypertensive Agents
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action