Early Manipulation of Arterial Blood Pressure in Acute Ischemic Stroke (MAPAS): Results of a Randomized Controlled Trial.

INTRODUCTION: There is uncertainty over the optimal level of systolic blood pressure (SBP) in the setting of acute ischemic stroke (AIS). The aim of this study was to determine the efficacy of the early manipulation of SBP in non-thrombolised patients. The key hypothesis under investigation was that clinical outcomes vary across ranges of SBP in AIS. METHODS: 218 patients were randomized within 12 h of AIS to maintain the SBP during 24 h within three ranges: Group 1 140-160 mmHg, Group 2 161-180 mmHg or Group 3 181-200 mmHg. Vasoactive drugs and fluids were used to achieve these targets. Good outcome was defined as a modified Rankin score 0-2 at 90-days. RESULTS: The median SBP in the three groups in 24 h was: 153 mmHg, 163 mmHg, and 178 mmHg, respectively, P < 0.0001. Good clinical outcome did not differ among the different groups (51% vs 52% vs 39%, P = 0.27). Symptomatic intracranial hemorrhage (SICH) was more frequent in the higher SBP range (1% vs 2.7% vs 9.1%, P = 0.048) with similar mortality rates. No patient had acute neurological deterioration related to the SBP reduction in the first 24 h. In our logistic regression analysis, the odds of having good clinical outcome was higher in Group 2 (OR 2.83) after adjusting for important confounders. Regardless of the assigned group, the probability of good outcome was 47% in patients who were manipulated to increase the BP, 42% to decrease and 62% in non-manipulated (P = 0.1). Adverse effects were limited to Group 2 (4%) and Group 3 (7.6%) and were associated with the use of norepinephrine (P = 0.05). CONCLUSIONS: Good outcome in 90 days was not significantly different among the 3 blood pressure ranges. After logistic regression analysis, the odds of having good outcome was greater in Group 2 (SBP 161-180 mmHg). SICH occurred more frequently in Group 3 (181-200 mmHg).

Early mobilization in ischemic stroke: a pilot randomized trial of safety and feasibility in a public hospital in Brazil.

BACKGROUND: The effect of early mobilization after acute stroke is still unclear, although some studies have suggested improvement in outcomes. We conducted a randomized, single-blind, controlled trial seeking to evaluate the feasibility, safety, and benefit of early mobilization for patients with acute ischemic stroke treated in a public teaching hospital in Southern Brazil. This report presents the feasibility and safety findings for the pilot phase of this trial. METHODS: The primary outcomes were time to first mobilization, total duration of mobilization, complications during early mobilization, falls within 3 months, mortality within 3 months, and medical complications of immobility. We included adult patients with CT- or MRI-confirmed ischemic stroke within 48 h of symptom onset who were admitted from March to November 2012 to the acute vascular unit or general emergency unit of a large urban emergency department (ED) at the Hospital de Clínicas de Porto Alegre. The severity of the neurological deficit on admission was assessed by the National Institutes of Health Stroke Scale (NIHSS). The NIHSS and modified Rankin Scale (mRS, functional outcome) scores were assessed on day 14 or at discharge as well as at 3 months. Activities of daily living (ADL) were measured with the modified Barthel Index (mBI) at 3 months. RESULTS: Thirty-seven patients (mean age 65 years, mean NIHSS score 11) were randomly allocated to an intervention group (IG) or a control group (CG). The IG received earlier (p = 0.001) and more frequent (p < 0.0001) mobilization than the CG. Of the 19 patients in the CG, only 5 (26%) underwent a physical therapy program during hospitalization. No complications (symptomatic hypotension or worsening of neurological symptoms) were observed in association with early mobilization. The rates of complications of immobility (pneumonia, pulmonary embolism, and deep vein thrombosis) and mortality were similar in the two groups. No statistically significant differences in functional independence, disability, or ADL (mBI ≥85) were observed between the groups at the 3-month follow-up. CONCLUSIONS: This pilot trial conducted at a public hospital in Brazil suggests that early mobilization after acute ischemic stroke is safe and feasible. Despite some challenges and limitations, early mobilization was successfully implemented, even in the setting of a large, complex ED, and without complications. Patients from the IG were mobilized much earlier than controls receiving the standard care provided in most Brazilian hospitals.