Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
45 participants
INTERVENTIONAL
2022-06-30
2024-06-30
Brief Summary
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Detailed Description
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Patients will be given 10.0mg\*3/day oral/nil propranolol alone or combined with 2.0g/day intravenous ceftriaxone over the course of 7 consecutive days. Neurological functions of these patients will be assessed at the baseline, day 7, 14, 30, and 90 after randomization. Head magnetic resonance imaging (MRI) will be performed at baseline and 7 days after randomization. Chest computed tomography (CT) will be performed within 7 days following randomization. Abdomen CT will be performed simultaneously with CT chest to evaluate spleen volume. For patients requiring acute endotracheal intubation upon admission, bronchoalveolar lavage fluid will be harvested at baseline and 7 days post-randomization. For all patients, 15 mL intravenous blood will be collected at baseline, days 3 and 7 after randomization. Bronchoalveolar lavage fluid and blood will be used to explore the peripheral and pulmonary immune status of patients. Urinary tract infection will be evaluated within 14 days based on routine urine test and bacterial culture.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Blank-control group
Patients will receive standard treatment.
No interventions assigned to this group
Oropranolol group
Propranolol will be administered at a dose of 10mg\*3/day over a course of 7 consecutive days after stroke onset.
Propranolol
Propranolol will be given at a dose of 10 mg orally, 3 times per day, for 7 consecutive days after stroke onset.
Propranolol + ceftriaxone group
Propranolol will be administered at a dose of 10mg\*3/day combined with 2g/day ceftriaxone over a course of 7 consecutive days after stroke onset.
Propranolol
Propranolol will be given at a dose of 10 mg orally, 3 times per day, for 7 consecutive days after stroke onset.
Ceftriaxone
Intravenously 2.0g/day for 7 consecutive days.
Interventions
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Propranolol
Propranolol will be given at a dose of 10 mg orally, 3 times per day, for 7 consecutive days after stroke onset.
Ceftriaxone
Intravenously 2.0g/day for 7 consecutive days.
Eligibility Criteria
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Inclusion Criteria
2. 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.
3. Clinical signs consistent with the diagnosis of stroke, including impairment of language, motor function, cognition, and/or gaze, vision, or neglect.
4. 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.
5. MRI or CT scan confirmed stroke.
6. 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.
7. TOAST: Large-artery atherosclerosis.
8. Signed and dated informed consent by the subject, legally authorized representative, or surrogate obtained.
Exclusion Criteria
2. Subjects considered as candidates for immediate surgical intervention by the neurosurgery service.
3. Pregnancy or parturition within previous 30 days or active lactation.
4. 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.
5. Use of beta blockers (propranolol, metoprolol, sotalol, carvedilol, bisoprolol, atenolol, esmolol) or antibiotics within 30 days.
6. Use of reserpine within the last 30 days.
7. Pre-stroke dementia or disability.
8. 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.
9. Severe liver, kidney disease, or malignancy, life expectancy is less than 14 days.
10. Bronchial asthma or COPD.
11. Cardiogenic shock.
12. Severe or acute heart failure.
13. Degree II-III atrioventricular block.
14. Sinus bradycardia (heart rate ≤75/min).
15. Known anergic to propranolol or amoxicillin.
16. Current participation in other interventional clinical trials.
17. Immunosuppressant therapy or known immunosuppression.
18. Inability to undergo neuroimaging with magnetic resonance.
60 Years
90 Years
ALL
No
Sponsors
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Tianjin Medical University General Hospital
OTHER
Responsible Party
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Fu-Dong Shi
Professor of Immunology, Neurologist-in-Chief
Locations
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Beijing Tiantan Hospital
Beijing, , China
Tianjin Medical University General Hospital
Tianjin, , China
Countries
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Central Contacts
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Facility Contacts
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Fu-Dong Shi, MD,PhD
Role: primary
Fu-Dong Shi, MD,PhD
Role: primary
Other Identifiers
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IRB2022-YX-001
Identifier Type: -
Identifier Source: org_study_id
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