Propranolol on Post Stroke Immune Status and Infection (NCT05375240) | Clinical Trial Compass
UnknownPhase 2
Propranolol on Post Stroke Immune Status and Infection
China45 participantsStarted 2022-06
Plain-language 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.
Who can participate
Age range60 Years – 90 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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.
What they're measuring
1
Incidence of pneumonia
Timeframe: Up to 7 days
Trial details
NCT IDNCT05375240
SponsorTianjin Medical University General Hospital
✕. 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.