A Phase 4 interventional study of Brevibloc, 10 Mg/mL Intravenous Solution and Nitroprusside, Sodium in Hemorrhagic Stroke, sponsored by Cristália Produtos Químicos Farmacêuticos Ltda.. Terminated at 7 sites in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-09.
Sponsored by Cristália Produtos Químicos Farmacêuticos Ltda. · Phase 4, Interventional, and Treatment
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:
214 studies on the registry are indexed under Hemorrhagic Stroke; 84 are open to participants now.
This study's enrollment of 20 is below the median of 59 across 147 interventional studies indexed under Hemorrhagic Stroke.
Browse Hemorrhagic Stroke studies →Cristália Produtos Químicos Farmacêuticos Ltda. is the lead sponsor of 14 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
10 mL/h every 5 minutes until reaching the pressure target
Drug: Brevibloc, 10 Mg/mL Intravenous Solution · Drug: Nitroprusside, Sodium
0.5 mcg / kg / min every 3 minutes until reaching the pressure target
Drug: Nitroprusside, Sodium
10 mL/h every 5 minutes until reaching the pressure target
Also known as: Brevibloc
0.5 ug/kg/min every 3 minutes until reaching the pressure target
Also known as: Nitroprus
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).
Time frame: 7 days
To compare the percentage of participants
To compare the percentage of participants with controlled systolic pressure (goal ≤ 140 mmHg)
Time frame: in the first hour of treatment between the groups.
Rankin Scale
To compare the ranks of the modified Rankin Scale (Applied by blind-investigator) between groups.
Time frame: 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.
Time frame: from admission to discharge or 7th day
MOCA scale
To compare the cognitive performance assessed between the groups.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: in 90 ± 4 days
Bradycardia
Compare the frequency and duration of major bradycardia (\<50 beats per minute) between groups.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 7 days
This study is terminated, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Cristália Produtos Químicos Farmacêuticos Ltda.