Esmolol for the Treatment of Hypertension After Intracerebral Hemorrhage Study (ETHICHS) (NCT03743103) | Clinical Trial Compass
TerminatedPhase 4
Esmolol for the Treatment of Hypertension After Intracerebral Hemorrhage Study (ETHICHS)
Stopped: Low enrollement
Brazil20 participantsStarted 2019-04-18
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.
What they're measuring
1
To evaluate comparatively the drug test and the comparator drug