Loading clinical trials...

TERMINATEDPHASE4

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

NCT03743103•Cristália Produtos Químicos Farmacêuticos Ltda.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Signature of the TCLE by participant or companion.
•2. Spontaneous intracerebral hemorrhage confirmed by computed tomography or magnetic resonance imaging and fit to be included in the study and initiate therapy with study medications within 6 hours after the event.
•3. Intracerebral hemorrhage (volume \< 30 cm3).
•4. No immediate surgical indication.
•5. Both sexes, aged above 18 years.
•6. Systolic blood pressure (\> 150 mmHg and \< 220 mmHg) measured on two occasions with a minimum difference of 2 minutes.

Exclusion Criteria

•1. Cerebral hemorrhage secondary to structural lesions in the brain, vascular malformations, coagulopathies or traumatic brain injury, if known at the time of randomization.
•2. Participant in deep coma, defined by the Glasgow Coma Scale score of 3 to 5.
•3. Uncontrolled asthmatic or COPD participants, if known at the time of randomization.
•4. Participants with Grade IV Heart Failure, defined as heart rate \< 50 beats per minute.
•5. Previous hemorrhagic stroke, if known at the time of randomization
•6. Participants with Cerebral Vascular Stroke.
•7. Participants who have presented previous ischemic cerebrovascular accident, if known at the time of randomization.
•8. Chronic diseases with life expectancy less than 3 months.
•9. Score ≥ 4 on the ICH score at the time of recruitment.
•10. In use of anticoagulants in the last 48 hours, if known at the time of randomization.
+5 more criteria

Locations (7)

Hospital Geral de Fortaleza

Fortaleza, Ceará, Brazil

Hospital São Rafael

Salvador, Estado de Bahia, Brazil

Hospital Madre Teresa

Belo Horizonte, Minas Gerais, Brazil

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Hospital das Clínicas da Faculdade de Medicina de Botucatu

Botucatu, São Paulo, Brazil

Hospital das Clínicas de Riberião Preto

Ribeirão Preto, São Paulo, Brazil

Universidade Federal de São Paulo

São Paulo, Brazil

Key Dates

Start Date

April 18, 2019

Primary Completion Date

October 31, 2021

Completion Date

October 31, 2021

Last Updated

February 9, 2023

Enrollment

ACTUAL participants

Conditions

Hemorrhagic Stroke

Interventions

Brevibloc, 10 Mg/mL Intravenous Solution

DRUG

Nitroprusside, Sodium

DRUG

Effects of tES Combined With CMDT Gait Training on Cognition, Cortical Activity, Spinal Motoneuron Excitability and Motor Performance in Stroke Individuals

NCT07236216

Hemorrhagic StrokeIschemic Stroke+2 more

View study

RECRUITINGPHASE4

Evaluation of the Efficacy of STRATAFIX for Neurosurgical Cranial and Spine Procedures

NCT07225101

Wound ClosureBrain Tumor Adult+4 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 9, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Esmolol for the Treatment of Hypertension After Intracerebral Hemorrhage Study (ETHICHS)

Inclusion Criteria

Exclusion Criteria

Effects of tES Combined With CMDT Gait Training on Cognition, Cortical Activity, Spinal Motoneuron Excitability and Motor Performance in Stroke Individuals

Evaluation of the Efficacy of STRATAFIX for Neurosurgical Cranial and Spine Procedures

Hospital Implementation of a Stroke Protocol for Emergency Evaluation and Disposition

Diagnostic Performance Study of the EMVision Emu™ Brain Scanner in the Detection of Intracranial Hemorrhage in Suspected Stroke Patients

Observational Study on Determinants of Dementia After Stroke

BCI-FES Therapy for Stroke Rehabilitation