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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
170
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
Samsung Medical Center, Sungkyunkwan University School of Medicine
Seoul, South Korea
RECRUITINGPrimary outcome
2 points improvement in NIH stroke scale (NIHSS) between days 0 and 7
Time frame: Day 0 and Day 7
Secondary efficacy outcome
1. modified Rankin scale (mRS)≤ 2 at day 90 2. modified Bathel index (mBI)≥ 90 at day 90 3. Infarct growth or new ischemic lesion on follow-up MRI
Time frame: Day 90 for 1, 2 and Day 7 for 3
Major safety outcome
1. Symptom aggravation by intracranial hemorrhage or cerebral edema (Clinical deterioration causing an increase in the NIHSS score of more than or equal to 4 points and if the hemorrhage or edema was liley to be the cause of the clinical deterioration) 2. Myocardial infarction 3. death from any cause
Time frame: 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
1. Intracranial hemorrhage on follow-up MRI 2. Side effects including headache, arrhythmia, chest pain, dysuria, or gastrointestinal hemorrhage
Time frame: 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
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