Antihypertensive treatment of acute cerebral hemorrhage*
Top Cited Papers
- 1 February 2010
- journal article
- research article
- Published by Ovid Technologies (Wolters Kluwer Health) in Critical Care Medicine
- Vol. 38 (2), 637-648
- https://doi.org/10.1097/ccm.0b013e3181b9e1a5
Abstract
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. A traditional phase I, dose-escalation, multicenter prospective study. Emergency departments and intensive care units. Patients with intracerebral hemorrhage with elevated systolic blood pressure ≥170 mm Hg who present to the emergency department within 6 hrs of symptom onset. 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. 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. 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.Keywords
This publication has 45 references indexed in Scilit:
- Changes in Cost and Outcome Among US Patients With Stroke Hospitalized in 1990 to 1991 and Those Hospitalized in 2000 to 2001Stroke, 2007
- Guidelines for the Management of Spontaneous Intracerebral Hemorrhage in AdultsStroke, 2007
- Determinants of Intracerebral Hemorrhage GrowthStroke, 2007
- Perihematomal Mitochondrial Dysfunction After Intracerebral HemorrhageStroke, 2006
- Lack of Evidence for an Association Between Hemodynamic Variables and Hematoma Growth in Spontaneous Intracerebral HemorrhageStroke, 2006
- Treatment of acute hypertension in patients with intracerebral hemorrhage using American Heart Association guidelines*Critical Care Medicine, 2006
- Early Hemorrhage Growth in Patients With Intracerebral HemorrhageStroke, 1997
- Predictors of Early Deterioration and Mortality in Black Americans With Spontaneous Intracerebral HemorrhageStroke, 1995
- Relation Between Blood Pressure and Outcome in Intracerebral HemorrhageStroke, 1995
- Volume of intracerebral hemorrhage. A powerful and easy-to-use predictor of 30-day mortality.Stroke, 1993