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

Study Overview
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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

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

Conditions
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Hypernatremia, Critical Illness

Intervention / Treatment
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* Drug: Hydrochlorothiazide 50Mg
* Drug: Placebos


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention<br>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<br>* 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<br>|
| Placebo Comparator: Control<br>placebo group will receive one tablet or equivalent volume of enteral solution of inert substance | Drug: Placebos<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hypernatremia correction | proportion of patients with hypernatremia correction (serum sodium below 145 mEq / L) at the end of Day 3 | DAY 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| renal replacement therapy | need to renal replacement therapy | 6 months | 
| mechanical ventilation | incidence of mechanical ventilation | 6 months | 
| vasoactive drugs | need for vasoactive drugs | 6 months | 
| mortality | hospital mortality | 6 months | 
| serious adverse events | incidence of serious adverse events 37/5000 incidence of serious adverse events | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypernatremia, Critical care