Ignite Creation Date:
2025-12-24 @ 7:22 PM
Ignite Modification Date:
2025-12-28 @ 5:49 PM
Study NCT ID:
NCT03743103
Status:
TERMINATED
Last Update Posted:
2023-02-09
First Post:
2018-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Esmolol for the Treatment of Hypertension After Intracerebral Hemorrhage Study (ETHICHS)
Sponsor:
Cristália Produtos Químicos Farmacêuticos Ltda.
Organization:
Study Overview
Official Title:
A Randomized, Exploratory, Open-label, Phase IV, Blinded Endpoint, Multicenter and Prospective Study to Evaluate the Effect of the Addition of Esmolol on the Current Therapeutic Regimen Used for the Treatment of Hemorrhagic Stroke
Status:
TERMINATED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low enrollement
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ETHICHS
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.
* 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: