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

ConditionHypertensive Intracerebral Hemorrhage
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorQianfoshan Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

600 Participants
are divided into 2 treatment groups
Group A: Urapidil Group1 intervention
Group B: Combination Group of Urapidil and Esmolol1 intervention

Trial outcomes

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.

Time frame
Three months after the onset of the disease

Secondary outcomes

1

Changes in the volume of acute intracranial hematoma

Change in hematoma volume per follow-up CT

Time frame
First seven days of hospitalization
2

Heart rate variability

Measures of cardiac autonomic nervous system activity

Time frame
First seven days of hospitalization
3

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

Comparing the blood pressure-lowering ability of the two groups

Time frame
First 24 hours after hospitalization
4

Modified Rankin Scale (mRS) score

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)

Time frame
Seventh day after the onset of the disease

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Qianfoshan Hospital

Lead sponsor

Source ClinicalTrials.gov

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