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

• Status: Unknown status
• Trial end date: 2020-03-10
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Sao Paulo
• Treatments: Hydrochlorothiazide

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