Histamine Glutamate Antagonism in Stroke
Acute Cerebrovascular Accident, Cerebral Edema
About this trial
This is an interventional treatment trial for Acute Cerebrovascular Accident focused on measuring Ischemic Stroke, Brain Edema, Diphenhydramine, Dextromethorphan, Famotidine
Eligibility Criteria
Inclusion Criteria:
- Subjects with age ≥18 years and ≤80 years at the time of screening.
- All Ischemic stroke patients with clinical and or radiological diagnosis.
- Subjects who have presented to hospital within 6 hours of symptom onset.
- The subject or his/ her legal representative is willing to undergo informed consent process prior to enrollment into this study.
Exclusion Criteria:
- Subject with age < 18 years and >80 years at the time of screening.
- Time of symptom onset cannot be determined.
- Subject who is pregnant or lactating.
- Subject who has asthma exacerbations in past 3 months.
- Subject who has hypersensitivity to dextromethorphan, diphenhydramine or famotidine, or other H2 antagonists or any component of the formulation.
- Serotonin syndrome.
- Concurrent administration with or within 2 weeks of discontinuing an MAO inhibitor
- Subjects with renal or hepatic failure.
- The subject or legal representative is unable to provide informed consent.
- The subject is medically unstable to participate in the trial as determined by the principal investigator.
- The subject has any end stage medical condition as determined by the principal investigator.
Sites / Locations
- Shands Hospital at University of Florida
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Active Comparator
Experimental
Experimental
Pantoprazole
Famotidine
Dextromethorphan
Diphenhydramine
Pantoprazole intravenous 40mg q daily as part of standard of care for stress ulcer prophylaxis along with current standard of care.
Famotidine 40 mg intravenous BID (maximum dose of 80 mg/day) for 4 days as part of standard of care for stress ulcer prophylaxis along with current standard of care.
Dextromethorphan 60 mg QID orally (maximum dose of 240 mg/day) for 2 days (total of 4 doses) along with current standard of care. If the drug can't be given orally, then feeding tube (G-tube, NG Tube or DHT) will be used for drug administration.
Diphenhydramine 12.5 mg BID intravenous or 25 mg BID oral for 4 days along with current standard of care.