Trials / Terminated
TerminatedNCT03743103
Esmolol for the Treatment of Hypertension After Intracerebral Hemorrhage Study (ETHICHS)
A Randomized, Exploratory, Open-label, Phase IV, Blinded Endpoint, Multicenter and Prospective Study to Evaluate the Effect of the Addition of Esmolol on the Current Therapeutic Regimen Used for the Treatment of Hemorrhagic Stroke
- Status
- Terminated
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- Cristália Produtos Químicos Farmacêuticos Ltda. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Because of its pharmacokinetic characteristics, such as short half-life and its safety profile, esmolol hydrochloride is a beta blocker suitable for venous use in the form of continuous infusion. Strategies that improve the blood pressure control of patients with hemorrhagic stroke during the first hours of hospitalization are determinant in controlling the hematoma expansion and determining factor in its prognosis. This study was designed with the objective of evaluating the beneficial effects of combining esmolol hydrochloride with sodium nitroprusside for the blood pressure control of participants with hemorrhagic stroke.
Detailed description
Participants with parenchymal intracranial hemorrhage (diagnosis confirmed by computed tomography or magnetic resonance imaging), and: * with systolic pressure \> 150 mmHg, * not contraindicated for treatment with beta-blockers, * who can start the drug treatment within 6 hours of the stroke, * having a target of ≤ 140 mmHg of systolic pressure within 1 hour after initiation of treatment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Brevibloc, 10 Mg/mL Intravenous Solution | 10 mL/h every 5 minutes until reaching the pressure target |
| DRUG | Nitroprusside, Sodium | 0.5 ug/kg/min every 3 minutes until reaching the pressure target |
Timeline
- Start date
- 2019-04-18
- Primary completion
- 2021-10-31
- Completion
- 2021-10-31
- First posted
- 2018-11-15
- Last updated
- 2023-02-09
Locations
7 sites across 1 country: Brazil
Source: ClinicalTrials.gov record NCT03743103. Inclusion in this directory is not an endorsement.