Status:
UNKNOWN
Propranolol on Post Stroke Immune Status and Infection
Lead Sponsor:
Tianjin Medical University General Hospital
Conditions:
Stroke
Cerebrovascular Disorders
Eligibility:
All Genders
60-90 years
Phase:
PHASE2
Brief Summary
Stroke-associated pneumonia (SAP) is one of the important risk factors influencing poor outcomes and death in stroke patients. Over the past two decades, accumulating evidence suggests that post-strok...
Detailed Description
Stroke patients meeting the inclusion criteria will be randomly assigned at a 1:1:1 ratio into groups of standard treatment (blank-controlled), propranolol, or propranolol + ceftriaxone. Patients wil...
Eligibility Criteria
Inclusion
- Age: 60 years older and less than 90 years.
- Onset of new neurological deficits within 24 hours at the time of randomization and propranolol treatment can be initiated within 24 hours of symptom onset.
- Clinical signs consistent with the diagnosis of stroke, including impairment of language, motor function, cognition, and/or gaze, vision, or neglect.
- Initial NIHSS score of 11 or greater or Total GCS score (aggregate of verbal, eye, and motor response scores) of 5 or greater and no more than 12 at time of enrollment.
- MRI or CT scan confirmed stroke.
- Inability to tolerate normal diet or fluids because of: a. impaired consciousness levels; b. failed clinical bedside swallowing assessment performed by a trained and qualified assessor; c. "nil orally" orders, nasogastric tubes, modified diet or requiring compensatory feeding techniques.
- TOAST: Large-artery atherosclerosis.
- Signed and dated informed consent by the subject, legally authorized representative, or surrogate obtained.
Exclusion
- Time of symptom onset that cannot be reliably assessed.
- Subjects considered as candidates for immediate surgical intervention by the neurosurgery service.
- Pregnancy or parturition within previous 30 days or active lactation.
- Coagulation disorders (platelet count less than 50x109/L, elevated baseline APTT or INR\>1.3) or use of anti-coagulant drugs within the last 24 hours.
- Use of beta blockers (propranolol, metoprolol, sotalol, carvedilol, bisoprolol, atenolol, esmolol) or antibiotics within 30 days.
- Use of reserpine within the last 30 days.
- Pre-stroke dementia or disability.
- Admission with any of following signs: 1). Fever\>38℃; 2). Signs of pneumonia in chest CT scan; 3). White blood cell count\>12000 or \<4000 /μL; 4). Cough, sputum or dyspnea; 5). Respiratory rate\>25.
- Severe liver, kidney disease, or malignancy, life expectancy is less than 14 days.
- Bronchial asthma or COPD.
- Cardiogenic shock.
- Severe or acute heart failure.
- Degree II-III atrioventricular block.
- Sinus bradycardia (heart rate ≤75/min).
- Known anergic to propranolol or amoxicillin.
- Current participation in other interventional clinical trials.
- Immunosuppressant therapy or known immunosuppression.
- Inability to undergo neuroimaging with magnetic resonance.
Key Trial Info
Start Date :
June 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2024
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT05375240
Start Date
June 1 2022
End Date
June 1 2024
Last Update
May 16 2022
Active Locations (2)
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1
Beijing Tiantan Hospital
Beijing, China, 100070
2
Tianjin Medical University General Hospital
Tianjin, China, 300052