A Phase 2 interventional study of Hydrochlorothiazide 50Mg and Placebos in Hypernatremia and Critical Illness, sponsored by University of Sao Paulo. Status unknown at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-30.
Sponsored by University of Sao Paulo · Phase 2, Interventional, and Treatment
HYDRA is a randomized clinical trial designed to evaluate safety and efficiency of hydrochlorothiazide in critical patients with hypernatremia
49 studies on the registry are indexed under Hypernatremia; 8 are open to participants now.
This study's planned enrollment of 184 is above the median of 64 across 32 interventional studies indexed under Hypernatremia.
Browse Hypernatremia studies →University of Sao Paulo is the lead sponsor of 1,035 studies on the registry; 95 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
placebo group will receive one tablet or equivalent volume of enteral solution of inert substance
Drug: Placebos
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
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
hypernatremia correction
proportion of patients with hypernatremia correction (serum sodium below 145 mEq / L) at the end of Day 3
Time frame: DAY 3
renal replacement therapy
need to renal replacement therapy
Time frame: 6 months
mechanical ventilation
incidence of mechanical ventilation
Time frame: 6 months
vasoactive drugs
need for vasoactive drugs
Time frame: 6 months
mortality
hospital mortality
Time frame: 6 months
serious adverse events
incidence of serious adverse events 37/5000 incidence of serious adverse events
Time frame: 6 months
This study is status unknown, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Hydrochlorothiazide