Hypernatremia, Critical Illness
Conditions
Keywords
hypernatremia, Critical care
Brief summary
HYDRA is a randomized clinical trial designed to evaluate safety and efficiency of hydrochlorothiazide in critical patients with hypernatremia
Interventions
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
DRUGPlacebos
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
Sponsors
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| hypernatremia correction | DAY 3 | proportion of patients with hypernatremia correction (serum sodium below 145 mEq / L) at the end of Day 3 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| renal replacement therapy | 6 months | need to renal replacement therapy |
| mechanical ventilation | 6 months | incidence of mechanical ventilation |
| vasoactive drugs | 6 months | need for vasoactive drugs |
| mortality | 6 months | hospital mortality |
| serious adverse events | 6 months | incidence of serious adverse events 37/5000 incidence of serious adverse events |
Countries
Brazil
Contacts
Primary ContactAndré LN Gobatto, p.h.d
Outcome results
None listed