Management of Cerebral Vascular Spasm in Posttraumatic Subarachnoid Hemorrhage Using Combination Therapy

NCT ID: NCT05131867

Last Updated: 2022-05-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-24
• Study Completion Date: 2022-05-24

Brief Summary

To evaluate the efficacy and safety of oral Nimodipine and IV milrinone combination therapy for management of cerebral spasm after aneurysmal subarachnoid hemorrhage.

Detailed Description

after being informed about the study and potential risks. All patients giving written consent will be randomized by double-blind manner into 2groups each one containing 15 patients.

Group 1(n =15 ):the patients will receive nimodipine (60 mg/4 hours) orally or via nasogastric tube In group 2(n =15 ): the patients will receive Oral Nimodipine (60 mg/4) will be given orally or in the gastric tube also from the first day of admission, then after the diagnosis of vasospasm is confirmed, start milrinone.

Conditions

Oral Nimodipine; Milrinone; Vascular Spasm After Traumatic Subarachnoidhaemorrhage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

triple H group

The patients will receive nimodipine (60 mg/4 hours) orally or via nasogastric tube from the first day of admission, then after the diagnosis of vasospasm is confirmed, Triple H therapy (hypertension, hypervolemia and hemodilution) will be started. norepnnephrine (0.01-0.2ug/kg/min) to mentain main arterial blood pressure \>100mmhg and hypervolemia to maintain the CVP around 12---14 mmHg and hemodilution to maintain the haematocrit between 30% and 33%.

Group Type: ACTIVE_COMPARATOR

nimodipine

Intervention Type: DRUG

(60 mg/4 hours) orally or via nasogastric tube

Milrinone group

The patients will receive oral Nimodipine (60 mg/4) will be given orally or in the gastric tube also from the first day of admission, then after the diagnosis of vasospasm is confirmed, start milrinone bolus of 0.1-0.2 mg/kg followed by 0.75mcg/k/min, if no response after 30min increase the infusion to 1-25mcg/kg/min with maintaining CVP 5:8.

Norepinephrine (0.01-0.2ug/kg/min) is used only to restore the mean arterial pressure (MAP) to its previous values If there was no recurrence of symptoms after 72 h, we decreased the milrinone infusion by 0.25 mcg/kg/min every 24 or 48 h until discontinuation. If there are any recurrent of symptoms of vasospasm, the patients are placed back on the dose they were previously receiving. If required, another Milrinone bolus is administered if the patient's deficits do not revert12.

Group Type: ACTIVE_COMPARATOR

Oral Nimodipine and milrinone

Intervention Type: DRUG

Oral Nimodipine then after the diagnosis of vasospasm is confirmed, start milrinone bolus

Interventions

nimodipine

(60 mg/4 hours) orally or via nasogastric tube

Intervention Type: DRUG

Oral Nimodipine and milrinone

Oral Nimodipine then after the diagnosis of vasospasm is confirmed, start milrinone bolus

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Adult patients admitted to our surgical ICU
• aged between (18-60) years old
• World Federation of Neurological Surgeons grades 1-3 Grades

Exclusion Criteria

• Aneurysmal SAH
• SAH with Fisher Grade I and IV,
• World Federation of Neurological Surgeons grade IV & V
• No informed consent,
• peripheral vascular disease
• Cardiac disease (heart block, severe valvular stenosis, cardiomyopathothy , ejection fraction<40%), Renal impairment (serum creatinine ≥ 1.4 mg.L-1), Hemodynamic instability

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zagazig University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Marwa Mohamed Medhat

lecture of anesthesia and surgical intensive care (Principal Investigator)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Aculty of Medicine,Zagazig University

Zagazig, Sharqia Province, Egypt

Faculty of Medicine,Zagazig University

Zagazig, Zagazig, Elsharkia,egypt, Egypt

Countries

Egypt

Other Identifiers

6919

Identifier Type: -

Identifier Source: org_study_id