Clinical trial NCT05131867: Management of Cerebral Vascular Spasm in Posttraumatic Subarachnoid Hemorrhage Using Combination Therapy
Official title: Management of Cerebral Vascular Spasm in Posttraumatic Subarachnoid Hemorrhage Using Combination Therapy of Oral Nimodipine and Intravenous Milrinone: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Oral Nimodipine
Milrinone
Vascular Spasm After Traumatic Subarachnoidhaemorrhage
Keywords: milrinone Oral Nimodipine
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2021-11-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Concentration of transcutaneous cerebral mixed oxygen saturation
timeFrame: every 24 hours up to 1 week
Secondary outcomes:
measure: Number of participants having cerebral infarction (cerebral infarction incidence)
timeFrame: every 48 hours up to 1 week
measure: Number of participants restore of the previous conscious level and motor state(Percentage of drug success)
timeFrame: 1 hour after administration of milrinone and 2 hours after administration of triple H therapy
measure: value of Glasgow coma scale
timeFrame: every 24 hours up to total days of ICU and hospital stay
measure: Number of participants develop one of adverse events
timeFrame: after administration of the study drugs up to 30 days
measure: Total ICU and hospital stay
timeFrame: up to 30 days after administration of the study drugs
measure: mortality rate
timeFrame: 30 day after administration of the study drugs
measure: value of Modified Rankin scale
timeFrame: 3,6,12 monthes after drug administration
measure: Glasgow Outcome Scale
timeFrame: 3,6,12 monthes after drug administration
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Aculty of Medicine,Zagazig University
state: El Sharkia
city: Zagazig
country: Egypt
facility: Faculty of Medicine,Zagazig University
state: Zagazig, Elsharkia,egypt
Study officials:
References: