Back to resultsManagement of Cerebral Vascular Spasm in Posttraumatic Subarachnoid Hemorrhage Using Combination Therapy
Primary Purpose
Oral Nimodipine, Milrinone, Vascular Spasm After Traumatic Subarachnoidhaemorrhage
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
nimodipine
Oral Nimodipine and milrinone
Sponsored by
About this trial
This is an interventional treatment trial for Oral Nimodipine focused on measuring milrinone Oral Nimodipine
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
Sites / Locations
- Aculty of Medicine,Zagazig University
- Faculty of Medicine,Zagazig University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
triple H group
Milrinone group
Arm Description
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%.
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.
Outcomes
Primary Outcome Measures
Concentration of transcutaneous cerebral mixed oxygen saturation
by forehead bilateral interconnected adhesive probes
Secondary Outcome Measures
Number of participants having cerebral infarction (cerebral infarction incidence)
detected by computed tomography
Number of participants restore of the previous conscious level and motor state(Percentage of drug success)
restore of the previous conscious level and motor state
value of Glasgow coma scale
with minimum scale vlue of 3 is the worst and maximum value of 16 indicate better outcome
Number of participants develop one of adverse events
hypotension ,bradycardia,hypotesion
Total ICU and hospital stay
mortality rate
Number of participants died within 30 day after administration of the study drugs
value of Modified Rankin scale
Level 0: no symptoms Level 1: no significant disability, despite symptoms; able to perform all usual duties and activities Level 2: slight disability unable to perform all previous activities but able to look after own affairs without assistance Level 3: moderate disability; requires some help, but able to walk without assistance.
Level 4: moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance Level 5: sever disability; bedridden, incontinent and requires nursing care and attention
Glasgow Outcome Scale
1. Dead: As a direct result of brain trauma, or … due to secondary complications or other complications" "2. Vegetative State: Patients who remain unresponsive and speechless…." "3. Severe Disability: The The patient is conscious but needs the assistance of another person for some activities of daily living every day.…." "4. Moderate Disability: Such a patient is able to look after himself at home, to get out and about to the shops and to travel by public transport. However, some previous activities, either at work or in social life, are now no longer possible by reason of either physical or mental deficit…." "5. Good Recovery: This indicates the capacity to resume normal occupational and social activities, although there may be minor physical or mental deficits…social outcome should be included in the assessment here, such as leisure activities and family relationships..
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05131867
Brief Title
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
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
November 24, 2021 (Actual)
Primary Completion Date
May 23, 2022 (Actual)
Study Completion Date
May 24, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zagazig University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Nimodipine, Milrinone, Vascular Spasm After Traumatic Subarachnoidhaemorrhage
Keywords
milrinone Oral Nimodipine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
double
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
triple H group
Arm Type
Active Comparator
Arm Description
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%.
Arm Title
Milrinone group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
nimodipine
Intervention Description
(60 mg/4 hours) orally or via nasogastric tube
Intervention Type
Drug
Intervention Name(s)
Oral Nimodipine and milrinone
Intervention Description
Oral Nimodipine then after the diagnosis of vasospasm is confirmed, start milrinone bolus
Primary Outcome Measure Information:
Title
Concentration of transcutaneous cerebral mixed oxygen saturation
Description
by forehead bilateral interconnected adhesive probes
Time Frame
every 24 hours up to 1 week
Secondary Outcome Measure Information:
Title
Number of participants having cerebral infarction (cerebral infarction incidence)
Description
detected by computed tomography
Time Frame
every 48 hours up to 1 week
Title
Number of participants restore of the previous conscious level and motor state(Percentage of drug success)
Description
restore of the previous conscious level and motor state
Time Frame
1 hour after administration of milrinone and 2 hours after administration of triple H therapy
Title
value of Glasgow coma scale
Description
with minimum scale vlue of 3 is the worst and maximum value of 16 indicate better outcome
Time Frame
every 24 hours up to total days of ICU and hospital stay
Title
Number of participants develop one of adverse events
Description
hypotension ,bradycardia,hypotesion
Time Frame
after administration of the study drugs up to 30 days
Title
Total ICU and hospital stay
Time Frame
up to 30 days after administration of the study drugs
Title
mortality rate
Description
Number of participants died within 30 day after administration of the study drugs
Time Frame
30 day after administration of the study drugs
Title
value of Modified Rankin scale
Description
Level 0: no symptoms Level 1: no significant disability, despite symptoms; able to perform all usual duties and activities Level 2: slight disability unable to perform all previous activities but able to look after own affairs without assistance Level 3: moderate disability; requires some help, but able to walk without assistance.
Level 4: moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance Level 5: sever disability; bedridden, incontinent and requires nursing care and attention
Time Frame
3,6,12 monthes after drug administration
Title
Glasgow Outcome Scale
Description
1. Dead: As a direct result of brain trauma, or … due to secondary complications or other complications" "2. Vegetative State: Patients who remain unresponsive and speechless…." "3. Severe Disability: The The patient is conscious but needs the assistance of another person for some activities of daily living every day.…." "4. Moderate Disability: Such a patient is able to look after himself at home, to get out and about to the shops and to travel by public transport. However, some previous activities, either at work or in social life, are now no longer possible by reason of either physical or mental deficit…." "5. Good Recovery: This indicates the capacity to resume normal occupational and social activities, although there may be minor physical or mental deficits…social outcome should be included in the assessment here, such as leisure activities and family relationships..
Time Frame
3,6,12 monthes after drug administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Aculty of Medicine,Zagazig University
City
Zagazig
State/Province
El Sharkia
ZIP/Postal Code
44519
Country
Egypt
Facility Name
Faculty of Medicine,Zagazig University
City
Zagazig
State/Province
Zagazig, Elsharkia,egypt
ZIP/Postal Code
44519
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
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Management of Cerebral Vascular Spasm in Posttraumatic Subarachnoid Hemorrhage Using Combination Therapy
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