Oral NimodipinePhase 2NCT05131867
Management of Cerebral Vascular Spasm in Posttraumatic Subarachnoid Hemorrhage Using Combination Therapy
A Phase 2 study testing nimodipine and Oral Nimodipine and milrinone in people with Oral Nimodipine and Milrinone, run by Zagazig University at 2 sites in Egypt.
Trial summary
To evaluate the efficacy and safety of oral Nimodipine and IV milrinone combination therapy for management of cerebral spasm after aneurysmal subarachnoid hemorrhage. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Oral Nimodipine, Milrinone, Vascular Spasm After Traumatic Subarachnoidhaemorrhage
- What is being tested?
- nimodipine and Oral Nimodipine and milrinone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesEgypt
- Study dates
- 24 Nov 2021to 24 May 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult patients admitted to our surgical ICU
- aged between (18-60) years old
- World Federation of Neurological Surgeons grades 1-3 Grades
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Aculty of Medicine,Zagazig University
Zagazig, Sharqia Province, 44519
Faculty of Medicine,Zagazig University
Zagazig, Zagazig, Elsharkia,egypt, 44519
About this study
Official title: Management of Cerebral Vascular Spasm in Posttraumatic Subarachnoid Hemorrhage Using Combination Therapy of Oral Nimodipine and Intravenous Milrinone: Randomized Clinical Trial
To evaluate the efficacy and safety of oral Nimodipine and IV milrinone combination therapy for management of cerebral spasm after aneurysmal subarachnoid hemorrhage.
Read the 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.
- Being tested
- nimodipine, Oral Nimodipine and milrinone
- Keywords
- milrinone Oral Nimodipine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nimodipineDrug
(60 mg/4 hours) orally or via nasogastric tube
Oral Nimodipine and milrinoneDrug
Oral Nimodipine then after the diagnosis of vasospasm is confirmed, start milrinone bolus
| Study group | Role | What they receive |
|---|---|---|
| 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%. Receives: 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. Receives: Drug: Oral Nimodipine and milrinone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of transcutaneous cerebral mixed oxygen saturation
by forehead bilateral interconnected adhesive probes
Measured: every 24 hours up to 1 week
Secondary outcomes (8)
Number of participants having cerebral infarction (cerebral infarction incidence)
detected by computed tomography
Measured: every 48 hours up to 1 week
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
Measured: 1 hour after administration of milrinone and 2 hours after administration of triple H therapy
value of Glasgow coma scale
with minimum scale vlue of 3 is the worst and maximum value of 16 indicate better outcome
Measured: every 24 hours up to total days of ICU and hospital stay
Number of participants develop one of adverse events
hypotension ,bradycardia,hypotesion
Measured: after administration of the study drugs up to 30 days
Total ICU and hospital stay
Measured: up to 30 days after administration of the study drugs
mortality rate
Number of participants died within 30 day after administration of the study drugs
Measured: 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
Measured: 3,6,12 monthes after drug administration
Glasgow Outcome Scale
- 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..
Measured: 3,6,12 monthes after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2021
- Study start24 Nov 2021
- Primary completion23 May 2022
- Study completion24 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral NimodipineStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Marwa Mohamed Medhat, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05131867
- Sponsor's protocol ID
- 6919
- Status last verified
- May 2022
- First submitted
- 7 Jul 2021
- Last updated
- 25 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Cerebral Vascular Spasm in Posttraumatic Subarachnoid Hemorrhage Using Combination Therapy of Oral Nimodipine and Intravenous Milrinone: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05131867
- Acronym / sponsor ID
- 6919
- Keywords
- milrinone Oral Nimodipine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 24 Nov 2021 (actual)
- Primary completion
- 23 May 2022 (actual)
- Study completion
- 24 May 2022 (actual)
- First posted
- 23 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| triple H group | Active comparator | Drug: nimodipineThe 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%. |
| Milrinone group | Active comparator | Drug: Oral Nimodipine and milrinoneThe 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adult patients admitted to our surgical ICU
- aged between (18-60) years old
- World Federation of Neurological Surgeons grades 1-3 Grades
Key exclusion criteria (6 listed)
- Aneurysmal SAH
- SAH with Fisher Grade I and IV,
- World Federation of Neurological Surgeons grade IV \& V
- No informed consent,
- peripheral vascular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nimodipine(60 mg/4 hours) orally or via nasogastric tube | Drug | triple H group |
| Oral Nimodipine and milrinoneOral Nimodipine then after the diagnosis of vasospasm is confirmed, start milrinone bolus | Drug | Milrinone group |
Primary outcome
Concentration of transcutaneous cerebral mixed oxygen saturation
Time frame: every 24 hours up to 1 week
by forehead bilateral interconnected adhesive probes
8 secondary outcomes
Number of participants having cerebral infarction (cerebral infarction incidence)
Time frame: every 48 hours up to 1 week
Number of participants restore of the previous conscious level and motor state(Percentage of drug success)
Time frame: 1 hour after administration of milrinone and 2 hours after administration of triple H therapy
value of Glasgow coma scale
Time frame: every 24 hours up to total days of ICU and hospital stay
Number of participants develop one of adverse events
Time frame: after administration of the study drugs up to 30 days
Total ICU and hospital stay
Time frame: up to 30 days after administration of the study drugs
mortality rate
Time frame: 30 day after administration of the study drugs
value of Modified Rankin scale
Time frame: 3,6,12 monthes after drug administration
Glasgow Outcome Scale
Time frame: 3,6,12 monthes after drug administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2022.
- Individual participant dataSharing planned: No
Related trials for Oral Nimodipine
Active, not recruitingPhase 3
Safety and Tolerability of GTX-104 Compared with Oral Nimodipine in Patients with ASAH
Aneurysmal Subarachnoid Hemorrhage (aSAH)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing nimodipine and Oral Nimodipine and milrinone in people with Oral Nimodipine and Milrinone, run by Zagazig University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of transcutaneous cerebral mixed oxygen saturation (time frame: every 24 hours up to 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2022.