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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Placebo Comparator | Patients will receive usual care and drug use in hospital. |
|
| Propranolol group | Experimental | Propranolol hydrochloride will be administered intravenously via pump at a initial dose of 5mg/day over a course of 7 consecutive days after randomization. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propranolol Hydrochloride | Drug | Day of randomization: propranolol IV vp for 7 days after randomization |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of stroke-associated pneumonia | Stroke-associated pneumonia diagnosed in accordance to a defined algorithm. | up to 7days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lu'an Hospital of Traditional Chinese Medicine | Lu'an | Anhui | China | |||
| Beijing Tiantan Hospital,Capital Medical University |
The study protocol,statistical analysis plan(SAP),informed consent form(ICF),clinical study report(CSR),analytic code will be shared with other researchers.
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Parallel Assignment
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Single (Outcomes Assessor)
| control group | Other | Patients will receive usual care and drug use in hospital |
|
Use the flow cytometry to measure the change of ratio and number of CD4+、CD8+、NK 、B cells at baseline, 3 days, 7 days |
| 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. | 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) | up to 90 days |
| Beijing |
| Beijing Municipality |
| 100070 |
| China |
| Third Affiliated Hospital, Soochow University | Changzhou | Jiangsu | 213003 | 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 |
| The 970th Hospital of the Chinese People's Liberation Army (Yantai Branch) | Yantai | Shandong | China |
| Tianjin Huanhu Hospital | Tianjin | Tianjin Municipality | China |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D020300 | Intracranial Hemorrhages |
| D002543 | Cerebral Hemorrhage |
| D000083302 | Hemorrhagic Stroke |
| D007239 | Infections |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D011433 | Propranolol |
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
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