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NCT06635707

Efficacy and Safety Study of Urapidil Alone or With Esmolol in Treating Acute Hypertensive Intracerebral Hemorrhage

Sponsor: Qianfoshan Hospital

View on ClinicalTrials.gov

Summary

The objective of this study is to investigate the efficacy and safety of urapidil monotherapy versus the combination of esmolol in treating participants with acute hypertensive intracerebral hemorrhage through a prospective, open-label, observational, multicenter clinical trial, aiming to provide guidance for clinicians in formulating rational treatment plans.

Official title: The Study on the Efficacy and Safety of Using Urapidil Alone or in Combination With Esmolol for the Treatment of Acute Hypertensive Intracerebral Hemorrhage: A Prospective, Open-label, Observational, Multicenter Research

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

OBSERVATIONAL

Enrollment

600

Start Date

2024-11-01

Completion Date

2026-12-01

Last Updated

2024-10-10

Healthy Volunteers

No

Interventions

DRUG

Urapidil

1. Control systolic blood pressure within 130-140mmHg using urapidil and maintain this level for 7 days; 2. Reduce intracranial pressure through dehydration therapy with mannitol, positioning of the body, and other means to prevent cerebral hernia. Surgical interventions such as decompressive craniectomy may be performed if necessary; 3. Aim for a body temperature control target of ≤37.5°C; 4. The anticoagulation reversal target is INR \< 1.5, with correction methods including the use of vitamin K, prothrombin complex concentrate (PCC), or fresh frozen plasma (FFP); 5. The blood glucose control targets are 6.1-7.8mmol/L for non-diabetic study participants and 7.8-10.0mmol/L for diabetic study participants.

DRUG

Urapidil and Esmolol

1. Utilize both urapidil and esmolol to control systolic blood pressure within 130-140mmHg and maintain this level for 7 days; 2. Reduce intracranial pressure through dehydration therapy with mannitol, strategic positioning of the body, and other measures to prevent cerebral hernia. Surgical interventions such as decompressive craniectomy may be performed if necessary; 3. Aim for a body temperature control target of ≤37.5°C; 4. The anticoagulation reversal target is INR \< 1.5, with correction methods including the administration of vitamin K, prothrombin complex concentrate (PCC), or fresh frozen plasma (FFP); 5. The blood glucose control targets are 6.1-7.8mmol/L for non-diabetic study participants and 7.8-10.0mmol/L for diabetic study participants.