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HYDRA is a randomized clinical trial designed to evaluate safety and efficiency of hydrochlorothiazide in critical patients with hypernatremia
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Active Comparator | 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. |
|
| Control | Placebo Comparator | placebo group will receive one tablet or equivalent volume of enteral solution of inert substance |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydrochlorothiazide 50Mg | Drug | 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| renal replacement therapy | need to renal replacement therapy | 6 months |
| mechanical ventilation | incidence of mechanical ventilation | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| André LN Gobatto, p.h.d | Contact | +5571988646501 | andregobatto@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| André LN Gobatto, p.h.d | University of Sao Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital das Clinicas da Faculdade de Medicina da Universidade de SĂ£o Paulo | Recruiting | SĂ£o Paulo | Brazil |
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| ID | Term |
|---|---|
| D006955 | Hypernatremia |
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D020969 | Disease Attributes |
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| ID | Term |
|---|---|
| D006852 | Hydrochlorothiazide |
| ID | Term |
|---|---|
| D002740 | Chlorothiazide |
| D001581 | Benzothiadiazines |
| D013449 | Sulfonamides |
| D013450 | Sulfones |
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| Placebos | Drug | 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 |
|
| 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 |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013457 |
| Sulfur Compounds |
| D009930 | Organic Chemicals |
| D049971 | Thiazides |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |