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Low enrollement
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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.
Participants with parenchymal intracranial hemorrhage (diagnosis confirmed by computed tomography or magnetic resonance imaging), and:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brevibloc, 10 Mg/mL Intravenous Solution | Experimental | 10 mL/h every 5 minutes until reaching the pressure target |
|
| Nitroprusside, Sodium | Active Comparator | 0.5 mcg / kg / min every 3 minutes until reaching the pressure target |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brevibloc, 10 Mg/mL Intravenous Solution | Drug | 10 mL/h every 5 minutes until reaching the pressure target |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| To compare the percentage of participants | To compare the percentage of participants with controlled systolic pressure (goal ≤ 140 mmHg) | in the first hour of treatment between the groups. |
| Rankin Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Geral de Fortaleza | Fortaleza | Ceará | 60150-160 | Brazil | ||
| Hospital São Rafael |
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| ID | Term |
|---|---|
| D000083302 | Hemorrhagic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C036604 | esmolol |
| D009599 | Nitroprusside |
| ID | Term |
|---|---|
| D005292 | Ferricyanides |
| D003486 | Cyanides |
| D000838 | Anions |
| D007477 | Ions |
| D004573 |
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| Nitroprusside, Sodium | Drug | 0.5 ug/kg/min every 3 minutes until reaching the pressure target |
|
|
To compare the ranks of the modified Rankin Scale (Applied by blind-investigator) between groups.
| in 90 ± 4 days |
| NIH Stroke Scale (NIHSS) and Glasgow Coma Scale | Compare the variation in scores on the NIH Stroke Scale (NIHSS) and Glasgow Coma Scale (whichever comes first) between groups. | from admission to discharge or 7th day |
| MOCA scale | To compare the cognitive performance assessed between the groups. | in 90 ± 4 days |
| Hematoma volume expansion and perihematoma volume of cerebral edema | To compare the percentages of between admission tomography and control tomography after the end of infusion of investigational products | 24 ± 4 hours |
| Severe hypotensive events with clinical consequences | To compare the frequency of severe hypotensive events with clinical consequencesrequiring corrective therapy with vasopressors during the use of investigational products between groups. | in 90 ± 4 days |
| Adverse events related with investigational product | To compare the frequency and intensity of adverse events related to the use of research products between groups. | in 90 ± 4 days |
| Severe cardiovascular events | Compare the frequency of severe cardiovascular events (acute myocardial infarction, cardiac arrest, arrhythmias, or the development of severe congestive heart failure) or major neurological complications (eg need for neurosurgery, intraventricular bypass placement, cerebral infarction, convulsive seizures, intoxication, neurological toxicity) within the first 90 days of follow-up between groups. | in 90 ± 4 days |
| Bradycardia | Compare the frequency and duration of major bradycardia (<50 beats per minute) between groups. | in 90 ± 4 days |
| QT interval variability | Compare the QT interval variability measured by Holter during the infusion period of the investigational products between the groups | during the infusion period |
| Frequency of changes in the ECO | Compare the frequency of changes in the Echocardiogram (Differences observed between the examination performed in the first 72 ± 4 hours and the return after 90 ± 3 days) between the groups. | in the first 72 ± 4 hours and the return after 90 ± 3 days |
| Frequency of changes in the level of BNP | To compare the frequency of changes in the level of B-type natriuretic peptide (BNP) measured at baseline times, 24 ± 4 and 72 ± 4 hours between groups. | at baseline times, 24 ± 4 and 72 ± 4 hours |
| Frequency of changes in baseline cardiac troponin levels | To compare the frequency of changes in baseline cardiac troponin levels, 24 ± 4 and 72 ± 4 hours | 24 ± 4 and 72 ± 4 hours |
| Frequency of intra-cranial hypertension | To compare the frequency of intra-cranial hypertension diagnosed by measuring the diameter of the optic nerve sheath by transorbital ultrasound daily for 7 days or high, whichever occurs first between the groups. | 7 days |
| Salvador |
| Estado de Bahia |
| 04011-032 |
| Brazil |
| Hospital Madre Teresa | Belo Horizonte | Minas Gerais | 30380-090 | Brazil |
| Hospital de Clínicas de Porto Alegre | Porto Alegre | Rio Grande do Sul | 90035-903 | Brazil |
| Hospital das Clínicas da Faculdade de Medicina de Botucatu | Botucatu | São Paulo | 18607-741 | Brazil |
| Hospital das Clínicas de Riberião Preto | Ribeirão Preto | São Paulo | 14015-130 | Brazil |
| Universidade Federal de São Paulo | São Paulo | 04022-002 | Brazil |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| Electrolytes |
| D007287 | Inorganic Chemicals |
| D005290 | Ferric Compounds |
| D058085 | Iron Compounds |
| D006856 | Hydrogen Cyanide |
| D017672 | Nitrogen Compounds |