Propranolol on Post Stroke Immune Status and Infection
A Randomized, Blank-controlled, Open Label Study of the Safety and Efficacy of Propranolol in Reducing Stroke Associated Pneumonia and Urinary Tract Infection
1 other identifier
interventional
45
1 country
2
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-stroke brain injury mobilizes the adrenergic system, which induces post-stroke immunosuppression and SAP. This study is designed to test the safety and efficacy of an adrenergic β-receptor blocker, propranolol, with or without combination of antibiotics, in reducing SAP in stroke patients. The underlying immune mechanisms will be investigated.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 stroke
Started Jun 2022
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 19, 2022
CompletedFirst Posted
Study publicly available on registry
May 16, 2022
CompletedStudy Start
First participant enrolled
June 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2024
CompletedMay 16, 2022
May 1, 2022
2 years
April 19, 2022
May 11, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of pneumonia
Stroke-associated pneumonia diagnosed in accordance to a defined algorithm.
Up to 7 days
Secondary Outcomes (10)
Assessment of clinical outcome by National Institute of Healthy Stroke Scale
Up to 90 days
Assessment of clinical outcome by modified Barthel Index
Up to 90 days
Assessment of clinical outcome by modified Rankin Scale
Up to 90 days
Assessment of clinical outcome by Glasgow Coma Scale
Up to 90 days
Incidence of urinary tract infection
Up to 14 days
- +5 more secondary outcomes
Study Arms (3)
Blank-control group
NO INTERVENTIONPatients will receive standard treatment.
Oropranolol group
EXPERIMENTALPropranolol will be administered at a dose of 10mg\*3/day over a course of 7 consecutive days after stroke onset.
Propranolol + ceftriaxone group
EXPERIMENTALPropranolol 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.
Interventions
Propranolol will be given at a dose of 10 mg orally, 3 times per day, for 7 consecutive days after stroke onset.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Beijing Tiantan Hospital
Beijing, 100070, China
Tianjin Medical University General Hospital
Tianjin, 300052, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Immunology, Neurologist-in-Chief
Study Record Dates
First Submitted
April 19, 2022
First Posted
May 16, 2022
Study Start
June 1, 2022
Primary Completion
June 1, 2024
Study Completion
June 1, 2024
Last Updated
May 16, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share