| Antihypertensive treatment of acute cerebral hemorrhage. | |
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MedLine Citation:
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PMID: 19770736 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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OBJECTIVE: To determine the feasibility and acute (i.e., within 72 hrs) safety of three levels of systolic blood pressure reduction in subjects with supratentorial intracerebral hemorrhage treated within 6 hrs after symptom onset. DESIGN: A traditional phase I, dose-escalation, multicenter prospective study. SETTINGS: Emergency departments and intensive care units. PATIENTS: Patients with intracerebral hemorrhage with elevated systolic blood pressure > or = 170 mm Hg who present to the emergency department within 6 hrs of symptom onset. INTERVENTION: Intravenous nicardipine to reduce systolic blood pressure to a target of: (1) 170 to 200 mm Hg in the first cohort of patients; (2) 140 to 170 mm Hg in the second cohort; and (3) 110 to 140 mm Hg in the third cohort. MEASUREMENTS AND MAIN RESULTS: Primary outcomes of interest were: (1) treatment feasibility (achieving and maintaining the systolic blood pressure goals for 18-24 hrs); (2) neurologic deterioration within 24 hrs; and (3) serious adverse events within 72 hrs. Safety stopping rules based on neurologic deterioration and serious adverse events were prespecified and approved by an NIH-appointed Data and Safety Monitoring Board, which provided oversight on subject safety. Each subject was followed-up for 3 months to preliminarily assess mortality and the clinical outcomes. A total of 18, 20, and 22 patients were enrolled in the respective three tiers of systolic blood pressure treatment goals. Overall, 9 of 60 patients had treatment failures (all in the last tier). A total of seven subjects with neurologic deterioration were observed: one (6%), two (10%), and four (18%) in tier one, two, and three, respectively. Serious adverse events were observed in one subject (5%) in tier two and in three subjects (14%) in tier three. However, the safety stopping rule was not activated in any of the tiers. Three (17%), two (10%), and five (23%) subjects in tiers one, two, and three, respectively, died within 3 months. CONCLUSIONS: The observed proportions of neurologic deterioration and serious adverse events were below the prespecified safety thresholds, and the 3-month mortality rate was lower than expected in all systolic blood pressure tiers. The results form the basis of a larger randomized trial addressing the efficacy of systolic blood pressure reduction in patients with intracerebral hemorrhage. |
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Authors:
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Publication Detail:
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Type: Clinical Trial, Phase I; Journal Article; Multicenter Study; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: Critical care medicine Volume: 38 ISSN: 1530-0293 ISO Abbreviation: Crit. Care Med. Publication Date: 2010 Feb |
Date Detail:
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Created Date: 2010-01-19 Completed Date: 2010-02-22 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 0355501 Medline TA: Crit Care Med Country: United States |
Other Details:
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Languages: eng Pagination: 637-48 Citation Subset: AIM; IM |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Aged Antihypertensive Agents / therapeutic use* Blood Pressure / drug effects Cerebral Hemorrhage / drug therapy* Dose-Response Relationship, Drug Female Humans Intensive Care Units Male Middle Aged Nicardipine / administration & dosage, therapeutic use* Prospective Studies |
| Grant Support | |
ID/Acronym/Agency:
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R0-1-NS44976-01A2/NS/NINDS NIH HHS; R01 NS057127/NS/NINDS NIH HHS; R01 NS062778/NS/NINDS NIH HHS; U01 NS054630/NS/NINDS NIH HHS; U01 NS059041/NS/NINDS NIH HHS |
| Chemical | |
Reg. No./Substance:
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0/Antihypertensive Agents; 55985-32-5/Nicardipine |
| Investigator | |
Investigator/Affiliation:
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Adnan I Qureshi / ; Nauman Tariq / ; Afskin A Divani / ; Jill Novitzke / ; Haitham H Hussein / ; Yuko Y Palesch / ; Renee' Martin / ; Catherine Dillon / ; Jawad F Kirmani / ; Mustapha A Ezzeddine / ; Ibrahim Mohammad / ; M Fareed K Suri / ; Pansy Harris-Lane / ; Jose I Suarez / ; Eliahu Feen / ; Warren Selman / ; Christopher Murphy / ; Stephan A Mayer / ; Augusto Parra / ; Kiwon Lee / ; Noeleen Ostapkovich / ; Nikolaos I H Papamitsakis / ; Spozhmy Panezai / ; Chinekwu Anyanwu / ; John Terry / ; Kelly Dickerson / ; Joshua Goldstein / ; Lauren Wendell / ; Yousef M Mohammad / ; Hoda Jradi / ; Salvador Cruz-Flores / ; Eve Holzemer / ; Gene Sung / ; Vangie Thomson / ; As'ad Ehtisham / ; Betty Brown / ; William R Clarke / ; Steven Greenberg / ; Leslie Ain McClure / ; Emmy R Miller / ; J Paul Muizelaar / ; Howard Yonas / |
| Comments/Corrections | |
Comment In:
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Crit Care Med. 2010 Feb;38(2):731-2
[PMID:
20083952
]
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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