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| Name | Class |
|---|---|
| Inje University | OTHER |
| Gyeongsang National University Hospital | OTHER |
| Seoul National University Bundang Hospital | OTHER |
| Keimyung University Dongsan Medical Center |
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The purpose of this study is to evaluate the safety and efficacy of the induced hypertension using phenylephrine in patients with noncardioembolic ischemic stroke.
The investigators hypothesized that phenylephrine induced-hypertension can result in good clinical response without serious complications in patients with noncardioembolic ischemic stroke.
See below
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phenylephrine | Experimental | Phenylephrine induced-hypertension arm |
|
| Conventional treatment | No Intervention | Control arm |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phenylephrine | Drug | Phenylephrine (0.12mg/mL) Starting dose: 10cc/hr Titration: increase 10cc/hr every 30-60min, maximum 160cc/hr rate: increase systolic blood pressure (SBP) 10-25mmHg /hr Target: initially 20% increase of initial SBP, up to improving NIHSS score or SBP 200mmHg |
| Measure | Description | Time Frame |
|---|---|---|
| Primary outcome | 2 points improvement in NIH stroke scale (NIHSS) between days 0 and 7 | Day 0 and Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary efficacy outcome |
| Day 90 for 1, 2 and Day 7 for 3 |
| Major safety outcome |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Oh Young Bang, MD | Contact | 82-10-3410-3599 | nmboy@unitel.co.kr | |
| Mi Hyun Seo, RN | Contact | 82-10-3410-0934 | mh84.seo@samsung.com |
| Name | Affiliation | Role |
|---|---|---|
| Oh Young Bang, MD | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center, Sungkyunkwan University School of Medicine | Recruiting | Seoul | 135710 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31645472 | Derived | Bang OY, Chung JW, Kim SK, Kim SJ, Lee MJ, Hwang J, Seo WK, Ha YS, Sung SM, Kim EG, Sohn SI, Han MK. Therapeutic-induced hypertension in patients with noncardioembolic acute stroke. Neurology. 2019 Nov 19;93(21):e1955-e1963. doi: 10.1212/WNL.0000000000008520. Epub 2019 Oct 23. |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D000083242 | Ischemic Stroke |
| D018450 | Disease Progression |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D010656 | Phenylephrine |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| OTHER |
| Yeungnam University Hospital | OTHER |
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|
| From date of randomization until the date of first documented progression by intracranial hemorrhage or cerebral edema, date of myocardial infarction, or date of death from any cause, whichever came first, assessed up to 3 months |
| Minor safety outcome |
| From date of randomization until the date of first documented intracranial hemorrhage on follow-up MRI, or date of first documented side effects, whichever came first, assessed up to 3 months |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000588 |
| Amines |