Xia Wang1, Hisatomi Arima1, Jie Yang1, Shihong Zhang1, Guojun Wu1, Mark Woodward1, Paula Muñoz-Venturelli1, Pablo M Lavados1, Christian Stapf1, Thompson Robinson1, Emma Heeley1, Candice Delcourt1, Richard I Lindley1, Mark Parsons1, John Chalmers1, Craig S Anderson2. 1. From The George Institute for Global Health, School of Public Health, the University of Sydney, Sydney, Australia (X.W., H.A., M.W., P.M.-V., E.H., C.D., R.I.L., J.C., C.S.A.); Neurology Department, Royal Prince Alfred Hospital, Sydney, Australia (C.D., C.S.A.); Department of Neurology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China (J.Y.); Department of Neurology, West China Hospital, Sichuan University, Chengdu, China (S.Z.); Department of Neurology, Hebei Yutian Hospital, Tangshan, China (G.W.); Servicio de Neurología, Departamento de Medicina Clínica Alemana, Universidad del Desarrollo, Santiago, Chile (P.M.-V., P.M.L.); Departamento de Ciencias Neurológicas, Universidad de Chile, Santiago, Chile (P.M.L.); Department of Neurology, APHP-Hôpital Lariboisière and DHU NeuroVasc Paris-Sorbonne, Université Paris Diderot-Sorbonne Paris Cité, Paris, France (C.S.); Department of Cardiovascular Sciences and NIHR Biomedical Research Unit in Cardiovascular Disease, University of Leicester, Leicester, United Kingdom (T.R.); Department of Medicine, Westmead Hospital Clinical School, Westmead, New South Wales, Australia (R.I.L.); and Department of Neurology, John Hunter Hospital, and Hunter Medical Research Institute, University of Newcastle, Newcastle, New South Wales, Australia (M.P.). 2. From The George Institute for Global Health, School of Public Health, the University of Sydney, Sydney, Australia (X.W., H.A., M.W., P.M.-V., E.H., C.D., R.I.L., J.C., C.S.A.); Neurology Department, Royal Prince Alfred Hospital, Sydney, Australia (C.D., C.S.A.); Department of Neurology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China (J.Y.); Department of Neurology, West China Hospital, Sichuan University, Chengdu, China (S.Z.); Department of Neurology, Hebei Yutian Hospital, Tangshan, China (G.W.); Servicio de Neurología, Departamento de Medicina Clínica Alemana, Universidad del Desarrollo, Santiago, Chile (P.M.-V., P.M.L.); Departamento de Ciencias Neurológicas, Universidad de Chile, Santiago, Chile (P.M.L.); Department of Neurology, APHP-Hôpital Lariboisière and DHU NeuroVasc Paris-Sorbonne, Université Paris Diderot-Sorbonne Paris Cité, Paris, France (C.S.); Department of Cardiovascular Sciences and NIHR Biomedical Research Unit in Cardiovascular Disease, University of Leicester, Leicester, United Kingdom (T.R.); Department of Medicine, Westmead Hospital Clinical School, Westmead, New South Wales, Australia (R.I.L.); and Department of Neurology, John Hunter Hospital, and Hunter Medical Research Institute, University of Newcastle, Newcastle, New South Wales, Australia (M.P.). canderson@georgeinstitute.org.au.
Abstract
BACKGROUND AND PURPOSE:Mannitol is often used to reduce cerebral edema in acute intracerebral hemorrhage but without strong supporting evidence of benefit. We aimed to determine the impact of mannitol on outcome among participants of the Intensive Blood Pressure Reduction in Acute Cerebral Hemorrhage Trial (INTERACT2). METHODS: INTERACT2 was an international, open, blinded end point, randomized controlled trial of 2839 patients with spontaneous intracerebral hemorrhage (<6 hours) and elevated systolic blood pressure allocated to intensive (target systolic blood pressure, <140 mm Hg within 1 hour) or guideline-recommended (target systolic blood pressure, <180 mm Hg) blood pressure-lowering treatment. Propensity score and multivariable analyses were performed to investigate the relationship between mannitol treatment (within 7 days) and poor outcome, defined by death or major disability on the modified Rankin Scale score (3-6) at 90 days. RESULTS: There was no significant difference in poor outcome between mannitol (n=1533) and nonmannitol (n=993) groups: propensity score-matched odds ratio of 0.90 (95% confidence interval, 0.75-1.09; P=0.30) and multivariable odds ratio of 0.87 (95% confidence interval, 0.71-1.07; P=0.18). Although a better outcome was suggested in patients with larger (≥15 mL) than those with smaller (<15 mL) baseline hematomas who received mannitol (odds ratio, 0.52 [95% confidence interval, 0.35-0.78] versus odds ratio, 0.91 [95% confidence interval, 0.72-1.15]; P homogeneity<0.03 in propensity score analyses), the association was not consistent in analyses across other cutoff points (≥10 and ≥20 mL) and for differing grades of neurological severity. Mannitol was not associated with excess serious adverse events. CONCLUSIONS:Mannitol seems safe but might not improve outcome in patients with acute intracerebral hemorrhage. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00716079.
RCT Entities:
BACKGROUND AND PURPOSE:Mannitol is often used to reduce cerebral edema in acute intracerebral hemorrhage but without strong supporting evidence of benefit. We aimed to determine the impact of mannitol on outcome among participants of the Intensive Blood Pressure Reduction in Acute Cerebral Hemorrhage Trial (INTERACT2). METHODS: INTERACT2 was an international, open, blinded end point, randomized controlled trial of 2839 patients with spontaneous intracerebral hemorrhage (<6 hours) and elevated systolic blood pressure allocated to intensive (target systolic blood pressure, <140 mm Hg within 1 hour) or guideline-recommended (target systolic blood pressure, <180 mm Hg) blood pressure-lowering treatment. Propensity score and multivariable analyses were performed to investigate the relationship between mannitol treatment (within 7 days) and poor outcome, defined by death or major disability on the modified Rankin Scale score (3-6) at 90 days. RESULTS: There was no significant difference in poor outcome between mannitol (n=1533) and nonmannitol (n=993) groups: propensity score-matched odds ratio of 0.90 (95% confidence interval, 0.75-1.09; P=0.30) and multivariable odds ratio of 0.87 (95% confidence interval, 0.71-1.07; P=0.18). Although a better outcome was suggested in patients with larger (≥15 mL) than those with smaller (<15 mL) baseline hematomas who received mannitol (odds ratio, 0.52 [95% confidence interval, 0.35-0.78] versus odds ratio, 0.91 [95% confidence interval, 0.72-1.15]; P homogeneity<0.03 in propensity score analyses), the association was not consistent in analyses across other cutoff points (≥10 and ≥20 mL) and for differing grades of neurological severity. Mannitol was not associated with excess serious adverse events. CONCLUSIONS:Mannitol seems safe but might not improve outcome in patients with acute intracerebral hemorrhage. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00716079.
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