Artículo de publicación ISIBackground
Whether rapid lowering of elevated blood pressure would improve the outcome in
patients with intracerebral hemorrhage is not known.
Methods
We randomly assigned 2839 patients who had had a spontaneous intracerebral
hemorrhage within the previous 6 hours and who had elevated systolic blood pressure
to receive intensive treatment to lower their blood pressure (with a target systolic
level of <140 mm Hg within 1 hour) or guideline-recommended treatment (with a
target systolic level of <180 mm Hg) with the use of agents of the physician’s choosing.
The primary outcome was death or major disability, which was defined as a score
of 3 to 6 on the modified Rankin scale (in which a score of 0 indicates no symptoms,
a score of 5 indicates severe disability, and a score of 6 indicates death) at 90 days.
A prespecified ordinal analysis of the modified Rankin score was also performed.
The rate of serious adverse events was compared between the two groups.
Results
Among the 2794 participants for whom the primary outcome could be determined,
719 of 1382 participants (52.0%) receiving intensive treatment, as compared with
785 of 1412 (55.6%) receiving guideline-recommended treatment, had a primary
outcome event (odds ratio with intensive treatment, 0.87; 95% confidence interval
[CI], 0.75 to 1.01; P = 0.06). The ordinal analysis showed significantly lower modified
Rankin scores with intensive treatment (odds ratio for greater disability, 0.87;
95% CI, 0.77 to 1.00; P = 0.04). Mortality was 11.9% in the group receiving intensive
treatment and 12.0% in the group receiving guideline-recommended treatment.
Nonfatal serious adverse events occurred in 23.3% and 23.6% of the patients in the
two groups, respectively.
Conclusions
In patients with intracerebral hemorrhage, intensive lowering of blood pressure
did not result in a significant reduction in the rate of the primary outcome of
death or severe disability. An ordinal analysis of modified Rankin scores indicated
improved functional outcomes with intensive lowering of blood pressure
SummaryBackgroundMagnesium sulphate is a neuroprotective agent that might improve outcome after aneurysmal subarachnoid haemorrhage by reducing the occurrence or improving the outcome of delayed cerebral ischaemia. We did a trial to test whether magnesium therapy improves outcome after aneurysmal subarachnoid haemorrhage.MethodsWe did this phase 3 randomised, placebo-controlled trial in eight centres in Europe and South America. We randomly assigned (with computer-generated random numbers, with permuted blocks of four, stratified by centre) patients aged 18 years or older with an aneurysmal pattern of subarachnoid haemorrhage on brain imaging who were admitted to hospital within 4 days of haemorrhage, to receive intravenous magnesium sulphate, 64 mmol/day, or placebo. We excluded patients with renal failure or bodyweight lower than 50 kg. Patients, treating physicians, and investigators assessing outcomes and analysing data were masked to the allocation. The primary outcome was poor outcome—defined as a score of 4–5 on the modified Rankin Scale—3 months after subarachnoid haemorrhage, or death. We analysed results by intention to treat. We also updated a previous meta-analysis of trials of magnesium treatment for aneurysmal subarachnoid haemorrhage. This study is registered with controlled-trials.com (ISRCTN 68742385) and the EU Clinical Trials Register (EudraCT 2006-003523-36).Findings1204 patients were enrolled, one of whom had his treatment allocation lost. 606 patients were assigned to the magnesium group (two lost to follow-up), 597 to the placebo (one lost to follow-up). 158 patients (26·2%) had poor outcome in the magnesium group compared with 151 (25·3%) in the placebo group (risk ratio [RR] 1·03, 95% CI 0·85–1·25). Our updated meta-analysis of seven randomised trials involving 2047 patients shows that magnesium is not superior to placebo for reduction of poor outcome after aneurysmal subarachnoid haemorrhage (RR 0·96, 95% CI 0·86–1·08).InterpretationIntravenous magnesium sulphate does not improve clinical outcome after aneurysmal subarachnoid haemorrhage, therefore routine administration of magnesium cannot be recommended.FundingNetherlands Heart Foundation, UK Medical Research Council.
, >5=0) predicted the probability of ICH growth (ranging from 3.4% for 0 point to 85.8% for 24 points) with good discrimination (C-statistic, 0.73) and calibration (Hosmer-Lemeshow P=0.82) in INTERACT1. Conclusions-The simple BRAIN score predicts the probability of hematoma growth in ICH. This could be used to improve risk stratification for research and clinical practice. Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT00226096 and NCT00716079.
Background: Patients with acute ischemic stroke (AIS) have impaired vasomotor reactivity, especially in the affected cerebral hemisphere, such that they may depend directly on systemic blood pressure to maintain perfusion to vulnerable ‘at risk' penumbral tissue. As the sitting up position may affect cerebral perfusion by decreasing cerebral blood flow (CBF) in salvageable tissue, positioning AIS patients with their head in a lying flat position could increase CBF through collateral circulation or gravitational force. We wished to quantify the effect of different head positions on mean flow velocity (MFV) by transcranial Doppler ultrasonography (TCD) in AIS patients to assess the potential for benefit (or harm) of head positioning in a clinical trial. Methods: We performed a systematic review and meta-analysis of observational studies with TCD to evaluate differences in cerebral MFV between the lying flat and sitting up head positions in AIS. For each study and each comparison, we obtained the mean value of changes in MFV and its variance. Results: A total of 303 studies were identified, but 298 were excluded for varying reasons; 4 papers met the inclusion criteria and 57 patients were included in the meta-analysis for calculation of the overall mean difference in MFV. We found a significant increase in MFV from a bed angle of 30 to 15° (4.6 cm/s, 95% confidence interval, CI, 2.9-6.2, p < 0.001) and from 30 to 0° (8.3 cm/s, 95% CI 5.3-11.3, p < 0.001) in the affected hemisphere but not on the normal side in AIS patients. Conclusions: In AIS patients, MFV increased significantly in the side affected by the stroke but not in the unaffected side when they were positioned in a lying flat head position at 0 or 15° compared to an upright head position at 30°. The clinical significance of these findings is now undergoing further randomized evaluation in the international multicenter Head Position in Acute Stroke Trial (HeadPoST).
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.