Stroke-associated pneumonia (SAP) is a grave complication of stroke and one of the most important predictors for patients' poor outcomes. Stroke associated pneumoniaSAP and other infections limited the overall efficacy of stroke management. Increasing evidence suggests that sympathetic nervous system activity contributes to post post-stroke immunosuppression and emergence of infections. This study is designed to test the safety and efficacy of an adrenergic β receptor blocker propranolol in reducing SAP in hemorrhagic stroke patients, in a multi-center, randomized, open-labeled, end point-blinded, trial.
This study will enroll 168 intracerebral hemorrhage patients who meet the inclusion criteria. ICH patients meet the inclusion criteria will be randomly assigned at a 1:1 ratio into groups of standard treatment (blank-controlled), or propranolol hydrochloride injection . Patients allocated to experimented group will be intravenously given initial dose at 5mg propranolol hydrochloride daily over a course of 7 consecutive days, The primary purpose of this study is to compare propranolol hydrochloride with standard treatment on reducing the 7-day risk of pneumonia when initiated within 24 hours of symptom onset in intracerebral hemorrhage. Both intent analysis (ITT) and per-protocol (PP) were used for analysis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
168
Day of randomization: propranolol IV vp for 7 days after randomization
Patients will receive usual care and drug use in hospital
Lu'an Hospital of Traditional Chinese Medicine
Lu'an, Anhui, China
Beijing Tiantan Hospital,Capital Medical University
Beijing, Beijing Municipality, China
Third Affiliated Hospital, Soochow University
Changzhou, Jiangsu, China
Weinan City Center hospital
Weinan, Shaanxi, China
Tangdu Hospital,Air Force Medical University
Xi'an, Shaanxi, China
Xi'an Central Hospital
Xi'an, Shaanxi, China
Qianxian People's Hospital
Xianyang, Shaanxi, China
The First People' Hospital of Xian Yang
Xianyang, Shaanxi, China
Xianyang hospital affliated of Yan'an University
Xianyang, Shaanxi, China
The 970th Hospital of the Chinese People's Liberation Army (Weihai Branch)
Weihai, Shandong, China
...and 2 more locations
Incidence of stroke-associated pneumonia
Stroke-associated pneumonia diagnosed in accordance to a defined algorithm.
Time frame: up to 7days
Clinical improvement
Modified Rankin Scale (mRS,0-6 scores, poor outcome defined as mRS≥4)are used to describe the clinical improvement at baseline, 7days, 14days, 30days and 90days.
Time frame: up to 90 days
Change in immunology function [ Time Frame: up to 7 days ](ONLY patients recruited from Beijing Tiantan hospital and Tangdu Hospital, Air Force Medical University will receive this evaluation)
Use the flow cytometry to measure the change of ratio and number of CD4+、CD8+、NK 、B cells at baseline, 3 days, 7 days
Time frame: up to 7 days
Spleen volume [ Time Frame: up to 7 days ] (ONLY patients recruited from Beijing Tiantan hospital and Tangdu Hospital, Air Force Medical University will receive this evaluation)
Spleen volume calculated based on Abdominal CT.
Time frame: up to 7 days
Adverse Event (AE)
Per protocol Adverse Event (AE), Adverse Reaction (AR), Serious Adverse Event / Reaction (SAE / SAR), and Suspected Unexpected Serious Adverse Reactions (SUSAR)
Time frame: up to 90 days
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