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

University of Sao Paulo

Status and phase: Unknown; Phase 2

Conditions: Hypernatremia; Critical Illness

Treatments: Drug: Placebos; Drug: Hydrochlorothiazide 50Mg

Study type: Interventional

Funder types: Other

Identifiers

NCT03658850

2.603.927

Details and patient eligibility

About

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

Enrollment: 184 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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184 participants in 2 patient groups, including a placebo group

Intervention

Active Comparator group

Description:

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.

Treatment:

Drug: Hydrochlorothiazide 50Mg

Control

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebos