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

NCT ID: NCT03743103

Last Updated: 2023-02-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-18
• Study Completion Date: 2021-10-31

Brief 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

Hemorrhagic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Brevibloc, 10 Mg/mL Intravenous Solution

10 mL/h every 5 minutes until reaching the pressure target

Group Type: EXPERIMENTAL

Brevibloc, 10 Mg/mL Intravenous Solution

Intervention Type: DRUG

10 mL/h every 5 minutes until reaching the pressure target

Nitroprusside, Sodium

Intervention Type: DRUG

0.5 ug/kg/min every 3 minutes until reaching the pressure target

Nitroprusside, Sodium

0.5 mcg / kg / min every 3 minutes until reaching the pressure target

Group Type: ACTIVE_COMPARATOR

Nitroprusside, Sodium

Intervention Type: DRUG

0.5 ug/kg/min every 3 minutes until reaching the pressure target

Interventions

Brevibloc, 10 Mg/mL Intravenous Solution

10 mL/h every 5 minutes until reaching the pressure target

Intervention Type: DRUG

Nitroprusside, Sodium

0.5 ug/kg/min every 3 minutes until reaching the pressure target

Intervention Type: DRUG

Other Intervention Names

Brevibloc; Nitroprus

Eligibility Criteria

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.

11. Patients with contraindication to any of the study medications.

12. Intubation Orotraqueal on arrival at the service.

13. Pheochromocytoma, if known at the time of randomization.

14. Patients with hyperthyroidism, if known at the time of randomization.

15. Known pregnancy or breastfeeding . At the discretion of the investigator, an examination for confirmation may be requested.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cristália Produtos Químicos Farmacêuticos Ltda.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

Brazil

Other Identifiers

CRT088

Identifier Type: -

Identifier Source: org_study_id