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

NCT03743103 | Terminated Phase 4

• 1 other identifier: CRT088
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 7

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.

Conditions

Hemorrhagic Stroke

Outcome Measures

Primary Outcomes (1)

• To evaluate comparatively the drug test and the comparator drug

  Variation of systolic and diastolic pressure during the time of use of the investigational products measured by ABPM (outpatient blood pressure monitoring).

  7 days

Secondary Outcomes (14)

• To compare the percentage of participants

  in the first hour of treatment between the groups.

• Rankin Scale

  in 90 ± 4 days

• NIH Stroke Scale (NIHSS) and Glasgow Coma Scale

  from admission to discharge or 7th day

• MOCA scale

  in 90 ± 4 days

• Hematoma volume expansion and perihematoma volume of cerebral edema

  24 ± 4 hours

Study Arms (2)

Brevibloc, 10 Mg/mL Intravenous Solution

EXPERIMENTAL

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

Drug: Brevibloc, 10 Mg/mL Intravenous Solution; Drug: Nitroprusside, Sodium

Nitroprusside, Sodium

ACTIVE COMPARATOR

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

Drug: Nitroprusside, Sodium

Interventions

Brevibloc, 10 Mg/mL Intravenous Solution DRUG

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

Also known as: Brevibloc

Brevibloc, 10 Mg/mL Intravenous Solution

Nitroprusside, Sodium DRUG

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

Also known as: Nitroprus

Brevibloc, 10 Mg/mL Intravenous Solution; Nitroprusside, Sodium

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signature of the TCLE by participant or companion.
• 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.
• Intracerebral hemorrhage (volume \< 30 cm3).
• No immediate surgical indication.
• Both sexes, aged above 18 years.
• Systolic blood pressure (\> 150 mmHg and \< 220 mmHg) measured on two occasions with a minimum difference of 2 minutes.

You may not qualify if:

• Cerebral hemorrhage secondary to structural lesions in the brain, vascular malformations, coagulopathies or traumatic brain injury, if known at the time of randomization.
• Participant in deep coma, defined by the Glasgow Coma Scale score of 3 to 5.
• Uncontrolled asthmatic or COPD participants, if known at the time of randomization.
• Participants with Grade IV Heart Failure, defined as heart rate \< 50 beats per minute.
• Previous hemorrhagic stroke, if known at the time of randomization
• Participants with Cerebral Vascular Stroke.
• Participants who have presented previous ischemic cerebrovascular accident, if known at the time of randomization.
• Chronic diseases with life expectancy less than 3 months.
• Score ≥ 4 on the ICH score at the time of recruitment.
• In use of anticoagulants in the last 48 hours, if known at the time of randomization.
• Patients with contraindication to any of the study medications.
• Intubation Orotraqueal on arrival at the service.
• Pheochromocytoma, if known at the time of randomization.
• Patients with hyperthyroidism, if known at the time of randomization.
• Known pregnancy or breastfeeding . At the discretion of the investigator, an examination for confirmation may be requested.

Sponsors & Collaborators

• Cristália Produtos Químicos Farmacêuticos Ltda.: lead

Study Sites (7)

Hospital Geral de Fortaleza

Fortaleza, Ceará, 60150-160, Brazil

Location

Hospital São Rafael

Salvador, Estado de Bahia, 04011-032, Brazil

Location

Hospital Madre Teresa

Belo Horizonte, Minas Gerais, 30380-090, Brazil

Location

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

Hospital das Clínicas da Faculdade de Medicina de Botucatu

Botucatu, São Paulo, 18607-741, Brazil

Location

Hospital das Clínicas de Riberião Preto

Ribeirão Preto, São Paulo, 14015-130, Brazil

Location

Universidade Federal de São Paulo

São Paulo, 04022-002, Brazil

Location

MeSH Terms

Conditions

Hemorrhagic Stroke

Interventions

esmolol; Nitroprusside

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ferricyanides; Cyanides; Anions; Ions; Electrolytes; Inorganic Chemicals; Ferric Compounds; Iron Compounds; Hydrogen Cyanide; Nitrogen Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2018
• First Posted: November 15, 2018
• Study Start: April 18, 2019
• Primary Completion: October 31, 2021
• Study Completion: October 31, 2021
• Last Updated: February 9, 2023

Record last verified: 2023-01

Locations

BR (7)