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

NCT06635707 | Not Yet Recruiting

• 1 other identifier: YXLL-KY-2024(066)
• Study Type: observational
• Target: 600
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Modified Rankin Scale (mRS)

  Evaluate the beneficial effect of blood pressure management with combined urapidil and esmolol on study participants by assessing the poor outcome rate, as indicated by the Modified Rankin Scale (mRS) scores (poor outcome: 4-6 points), three months after the onset of the disease.

  Three months after the onset of the disease

Secondary Outcomes (9)

• Changes in the volume of acute intracranial hematoma

  First seven days of hospitalization

• Heart rate variability

  First seven days of hospitalization

• Time taken for blood pressure to reach target levels after administering antihypertensive medications

  First 24 hours after hospitalization

• Modified Rankin Scale (mRS) score

  Seventh day after the onset of the disease

• In-hospital mortality rate

  From date of randomization until the date of death from any cause, assessed up to 3 months

Study Arms (2)

Urapidil Group

Urapidil Injection (Shijiazhuang Sipharm Co., Ltd., National Medical Products Administration Approval No. H20233626): Initially, administer a loading dose of 10mg via slow intravenous injection, observe for 5 minutes, and then adjust the infusion rate based on the patient's blood pressure, generally not exceeding 2mg/min.

Drug: Urapidil

Combination Group of Urapidil and Esmolol

Urapidil Injection (Shijiazhuang Sipharm Co., Ltd., National Medical Products Administration Approval No. H20233626): Initially, administer a loading dose of 10mg via slow intravenous injection, observe for 5 minutes, and then adjust the infusion rate based on the patient's blood pressure, generally not exceeding 2mg/min. Esmolol Injection (Qilu Pharmaceutical Co., Ltd., National Medical Products Administration Approval No. H19991058): Administer an intravenous bolus of 1mg/kg within 30 seconds, followed by a maintenance infusion rate not exceeding 300μg/kg/min, adjusted according to blood pressure readings.

Drug: Urapidil and Esmolol

Interventions

Urapidil DRUG

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.

Also known as: Ebrantil(34661-75-1)

Urapidil Group

Urapidil and Esmolol DRUG

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.

Also known as: 34661-75-1 and 81147-92-4

Combination Group of Urapidil and Esmolol

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Sample collection will be conducted for participants in the study of hypertensive intracerebral hemorrhage. Recruitment Locations: The First Affiliated Hospital of Shandong First Medical University (Shandong Qianfoshan Hospital), along with various other sub-centers.

You may qualify if:

• Participants in the study of acute hypertensive intracerebral hemorrhage aged between 18 and 80 years old;
• Participants with acute intracerebral hemorrhage (basal ganglia hemorrhage \< 50ml) confirmed by imaging within 6 hours of onset;
• Participants with systolic blood pressure \> 140mmHg upon admission;
• Participants who have signed the informed consent form.

You may not qualify if:

• Participants in the cerebral hemorrhage study who decline to have their disease management information collected and used and/or refuse to undergo subsequent follow-ups;
• Participants with allergies to the medication in question;
• Participants in the study of secondary cerebral hemorrhage resulting from tumors, vascular malformations, aneurysms, trauma, post-thrombolytic therapy, or cerebral arteriovenous thrombosis;
• Participants undergoing anticoagulant therapy or with coagulation disorders;
• Pregnant women;
• Participants with multiple organ failure;
• Participants deemed unsuitable for enrollment by the research staff due to other factors.

Sponsors & Collaborators

• Qianfoshan Hospital: lead

MeSH Terms

Conditions

Intracranial Hemorrhage, Hypertensive

Interventions

urapidil; esmolol

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jianjun Wang, Ph.D.

  Qianfoshan Hospital

  STUDY DIRECTOR

• Xueyan Cui, Ph.D.

  Qianfoshan Hospital

  STUDY DIRECTOR

Central Study Contacts

Shaofeng Yan, postdoc

CONTACT

15662793799; 2415@sdhospital.com.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: September 14, 2024
• First Posted: October 10, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 10, 2024

Record last verified: 2024-10