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

Critical Illness Clinical Trial

— HYDRA  

Official title:

Safety and Efficacy of Hydrochlorothiazide in the Treatment of Hypernatremia in Critically Ill Patients: a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03658850
• Other study ID #: 2.603.927
• Status: Recruiting
• Phase: Phase 2
• Start date: October 1, 2018
• Est. completion date: March 10, 2020

Study information

• Verified date: April 2019
• Source: University of Sao Paulo
• Contact: André LN Gobatto, p.h.d
• Phone: +5571988646501
• Email: andregobatto[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 184
• Est. completion date: March 10, 2020
• Est. primary completion date: December 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Hypernatremia

Intervention

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
• 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

Locations

Country	Name	City	State
Brazil	Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hypernatremia correction	proportion of patients with hypernatremia correction (serum sodium below 145 mEq / L) at the end of Day 3	DAY 3
Secondary	renal replacement therapy	need to renal replacement therapy	6 months
Secondary	mechanical ventilation	incidence of mechanical ventilation	6 months
Secondary	vasoactive drugs	need for vasoactive drugs	6 months
Secondary	mortality	hospital mortality	6 months
Secondary	serious adverse events	incidence of serious adverse events 37/5000 incidence of serious adverse events	6 months