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.
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 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
45
Propranolol will be given at a dose of 10 mg orally, 3 times per day, for 7 consecutive days after stroke onset.
Intravenously 2.0g/day for 7 consecutive days.
Beijing Tiantan Hospital
Beijing, China
Tianjin Medical University General Hospital
Tianjin, China
Incidence of pneumonia
Stroke-associated pneumonia diagnosed in accordance to a defined algorithm.
Time frame: Up to 7 days
Assessment of clinical outcome by National Institute of Healthy Stroke Scale
National Institute of Healthy Stroke Scale(0-42 score),higher scores mean a worse outcome.
Time frame: Up to 90 days
Assessment of clinical outcome by modified Barthel Index
Modified Barthel Index(0-100 score),higher scores mean a better outcome.
Time frame: Up to 90 days
Assessment of clinical outcome by modified Rankin Scale
Modified Rankin Scale(0-5 score),higher scores mean a worse outcome.
Time frame: Up to 90 days
Assessment of clinical outcome by Glasgow Coma Scale
Glasgow Coma Scale(0-15),higher scores mean a better outcome.
Time frame: Up to 90 days
Incidence of urinary tract infection
Urinary tract infection diagnosed with defined criteria.
Time frame: Up to 14 days
Incidence of sepsis
Sepsis diagnosed with defined criteria.
Time frame: Up to 14 days
Alterations of spleen volume
Spleen volume will be evaluated within 7 days via abdomen CT scan.
Time frame: Up to 7 days
Single cell sequencing results of immune cells from blood and bronchoalveolar lavage fluid
Single cell sequencing of immune cells from blood and bronchoalveolar lavage fluid will be conducted at baseline and 7 days after stroke onset.
Time frame: Up to 7 days
Concentration of soluble protein in blood and bronchoalveolar lavage fluid
Soluble proteins in blood and bronchoalveolar lavage fluid will be evaluated by O-link at baseline and 7 days after stroke onset
Time frame: Up to 7 days
Counts of lymphocytes in blood
Counts of lymphocytes will be evaluated by flow cytometry at baseline, day 3, and day 7 post stroke onset
Time frame: Up to 7 days
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