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

NCT ID: NCT03658850

Last Updated: 2019-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

184 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2020-03-10

Brief Summary

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

Detailed Description

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Conditions

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Hypernatremia Critical Illness

Keywords

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hypernatremia Critical care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Hydrochlorothiazide 50Mg

Intervention Type DRUG

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

Control

placebo group will receive one tablet or equivalent volume of enteral solution of inert substance

Group Type PLACEBO_COMPARATOR

Placebos

Intervention Type DRUG

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

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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André Luiz Nunes Gobatto

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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André LN Gobatto, p.h.d

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

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Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo

São Paulo, , Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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André LN Gobatto, p.h.d

Role: CONTACT

Phone: +5571988646501

Email: [email protected]

Facility Contacts

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André LN Gobatto, M.D.

Role: primary

Other Identifiers

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2.603.927

Identifier Type: -

Identifier Source: org_study_id