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

NCT06635707 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 600

Last updated 2024-10-10

No results posted yet for this study

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.

Conditions

  • Hypertensive Intracerebral Hemorrhage

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.

Sponsors & Collaborators

  • Qianfoshan Hospital

    lead OTHER

Principal Investigators

  • Jianjun Wang, Ph.D. · Qianfoshan Hospital

  • Xueyan Cui, Ph.D. · Qianfoshan Hospital

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-01
Primary Completion
2026-11-01
Completion
2026-12-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06635707 on ClinicalTrials.gov