Document Detail


Antihypertensive treatment of acute cerebral hemorrhage.
MedLine Citation:
PMID:  19770736     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
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Publication Detail:
Type:  Clinical Trial, Phase I; Journal Article; Multicenter Study; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Critical care medicine     Volume:  38     ISSN:  1530-0293     ISO Abbreviation:  Crit. Care Med.     Publication Date:  2010 Feb 
Date Detail:
Created Date:  2010-01-19     Completed Date:  2010-02-22     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0355501     Medline TA:  Crit Care Med     Country:  United States    
Other Details:
Languages:  eng     Pagination:  637-48     Citation Subset:  AIM; IM    
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MeSH Terms
Descriptor/Qualifier:
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:
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:
0/Antihypertensive Agents; 55985-32-5/Nicardipine
Investigator
Investigator/Affiliation:
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:
Crit Care Med. 2010 Feb;38(2):731-2   [PMID:  20083952 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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