Efficacy and Safety of Propranolol for the Post-Stroke Pneumonia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 168
- 试验地点
- 12
- 主要终点
- Incidence of stroke-associated pneumonia
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years older and less than 80 years.
- •Onset of new neurological deficits within≤24 hours at the time of randomization
- •CT scan demonstrates supratentorial parenchymal hemorrhage and volume of hematoma≥10ml .
- •Initial NIHSS score of 11 or greater and less than 25 scores.
- •Initial GCS score (aggregate of verbal, eye, and motor response scores) of 8 or greater at time of enrollment.
- •Admission without infection signs.
- •Signed and dated informed consent by the subject, legally authorized representative, or surrogate obtained.
排除标准
- •Subjects is considered a candidate for immediate surgical intervention by the neurosurgery service, including surgical evacuation of hematoma, decompressive craniectomy, minimally invasive aspiration of hematoma, and ventricular shunt or external ventricular drainage for intracerebral hemorrhage into the ventricle.
- •Patients with primary intraventricular hemorrhage or cerebral hemorrhage due to a definite cause, such as trauma, vascular malformation, aneurysm, coagulopathy, anticoagulant or antiplatelet drugs, thrombolytic therapy, post-infarction hemorrhagic transformation, hematologic disease, moyamoya disease, primary or metastatic tumor, venous sinus thrombosis, vasculitis, etc.
- •Previous stroke or pre-onset motor disability (mRS≥1)
- •Pregnancy or parturition within previous 30 days or active lactation.
- •Use of beta blockers (propranolol, metoprolol, sotalol, carvedilol, bisoprolol, atenolol, esmolol, etc.) or reserpine within the last 30 days.
- •Bronchial asthma or chronic obstructive pulmonary disease
- •Cardiogenic shock or severe or acute heart failure.
- •Degree II-III atrioventricular block or sinus bradycardia or heart rate ≤65/min.
- •Known sensitivity to propranolol.
- •Severe hepatic or renal insufficiency
- •History of Malignancy
- •Currently participating in other interventional clinical trials.
- •Immunosuppressant therapy or known immunosuppression.
研究组 & 干预措施
Control group
Patients will receive usual care and drug use in hospital.
干预措施: control group (Other)
Propranolol group
Propranolol hydrochloride will be administered intravenously via pump at a initial dose of 5mg/day over a course of 7 consecutive days after randomization.
干预措施: Propranolol Hydrochloride (Drug)
结局指标
主要结局
Incidence of stroke-associated pneumonia
时间窗: up to 7days
Stroke-associated pneumonia diagnosed in accordance to a defined algorithm.
次要结局
- 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）(up to 7 days)
- Clinical improvement(up to 90 days)
- Adverse Event (AE)(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）(up to 7 days)
研究者
Fu-Dong Shi
professor
Beijing Tiantan Hospital