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

NCT05131867 | Completed Phase 2

• 1 other identifier: 6919
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Oral Nimodipine; Milrinone; Vascular Spasm After Traumatic Subarachnoidhaemorrhage

Keywords

milrinone Oral Nimodipine

Outcome Measures

Primary Outcomes (1)

• Concentration of transcutaneous cerebral mixed oxygen saturation

  by forehead bilateral interconnected adhesive probes

  every 24 hours up to 1 week

Secondary Outcomes (8)

• Number of participants having cerebral infarction (cerebral infarction incidence)

  every 48 hours up to 1 week

• Number of participants restore of the previous conscious level and motor state(Percentage of drug success)

  1 hour after administration of milrinone and 2 hours after administration of triple H therapy

• value of Glasgow coma scale

  every 24 hours up to total days of ICU and hospital stay

• Number of participants develop one of adverse events

  after administration of the study drugs up to 30 days

• Total ICU and hospital stay

  up to 30 days after administration of the study drugs

Study Arms (2)

triple H group

ACTIVE COMPARATOR

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%.

Drug: nimodipine

Milrinone group

ACTIVE COMPARATOR

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.

Drug: Oral Nimodipine and milrinone

Interventions

nimodipine DRUG

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

triple H group

Oral Nimodipine and milrinone DRUG

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

Milrinone group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (2)

Aculty of Medicine,Zagazig University

Zagazig, Sharqia Province, 44519, Egypt

Location

Faculty of Medicine,Zagazig University

Zagazig, Zagazig, Elsharkia,egypt, 44519, Egypt

Location

MeSH Terms

Interventions

Nimodipine; Milrinone

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nicotinic Acids; Amrinone; Aminopyridines; Amines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecture of anesthesia and surgical intensive care (Principal Investigator)

Study Record Dates

• First Submitted: July 7, 2021
• First Posted: November 23, 2021
• Study Start: November 24, 2021
• Primary Completion: May 23, 2022
• Study Completion: May 24, 2022
• Last Updated: May 25, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)