Induced Hypertension for Delayed Cerebral Ischemia After Aneurysmal Subarachnoid Hemorrhage: A Randomized Clinical Trial.

Autor: Gathier CS; From the Department of Intensive Care Medicine, Brain Center Rudolf Magnus (C.S.G., A.J.C.S.), Department of Neurology and Neurosurgery, Brain Center Rudolf Magnus (C.S.G., B.H.V., G.J.E.R.), and Department of Radiology (J.W.D.), University Medical Center Utrecht, Utrecht University, the Netherlands; Department of Critical Care, University Medical Center Groningen, University of Groningen, the Netherlands (W.M.v.d.B.); Department of Intensive Care and Erasmus MC Stroke Center, Erasmus MC University Medical Center, Rotterdam, the Netherlands (M.v.d.J.); Department of Intensive Care, Academic Medical Center Amsterdam, University of Amsterdam, the Netherlands (M.C.M.); and Department of Intensive Care, Elisabeth-TweeSteden Hospital (ETZ), Tilburg, the Netherlands (A.W.O.). c.s.gathier-2@umcutrecht.nl., van den Bergh WM; From the Department of Intensive Care Medicine, Brain Center Rudolf Magnus (C.S.G., A.J.C.S.), Department of Neurology and Neurosurgery, Brain Center Rudolf Magnus (C.S.G., B.H.V., G.J.E.R.), and Department of Radiology (J.W.D.), University Medical Center Utrecht, Utrecht University, the Netherlands; Department of Critical Care, University Medical Center Groningen, University of Groningen, the Netherlands (W.M.v.d.B.); Department of Intensive Care and Erasmus MC Stroke Center, Erasmus MC University Medical Center, Rotterdam, the Netherlands (M.v.d.J.); Department of Intensive Care, Academic Medical Center Amsterdam, University of Amsterdam, the Netherlands (M.C.M.); and Department of Intensive Care, Elisabeth-TweeSteden Hospital (ETZ), Tilburg, the Netherlands (A.W.O.)., van der Jagt M; From the Department of Intensive Care Medicine, Brain Center Rudolf Magnus (C.S.G., A.J.C.S.), Department of Neurology and Neurosurgery, Brain Center Rudolf Magnus (C.S.G., B.H.V., G.J.E.R.), and Department of Radiology (J.W.D.), University Medical Center Utrecht, Utrecht University, the Netherlands; Department of Critical Care, University Medical Center Groningen, University of Groningen, the Netherlands (W.M.v.d.B.); Department of Intensive Care and Erasmus MC Stroke Center, Erasmus MC University Medical Center, Rotterdam, the Netherlands (M.v.d.J.); Department of Intensive Care, Academic Medical Center Amsterdam, University of Amsterdam, the Netherlands (M.C.M.); and Department of Intensive Care, Elisabeth-TweeSteden Hospital (ETZ), Tilburg, the Netherlands (A.W.O.)., Verweij BH; From the Department of Intensive Care Medicine, Brain Center Rudolf Magnus (C.S.G., A.J.C.S.), Department of Neurology and Neurosurgery, Brain Center Rudolf Magnus (C.S.G., B.H.V., G.J.E.R.), and Department of Radiology (J.W.D.), University Medical Center Utrecht, Utrecht University, the Netherlands; Department of Critical Care, University Medical Center Groningen, University of Groningen, the Netherlands (W.M.v.d.B.); Department of Intensive Care and Erasmus MC Stroke Center, Erasmus MC University Medical Center, Rotterdam, the Netherlands (M.v.d.J.); Department of Intensive Care, Academic Medical Center Amsterdam, University of Amsterdam, the Netherlands (M.C.M.); and Department of Intensive Care, Elisabeth-TweeSteden Hospital (ETZ), Tilburg, the Netherlands (A.W.O.)., Dankbaar JW; From the Department of Intensive Care Medicine, Brain Center Rudolf Magnus (C.S.G., A.J.C.S.), Department of Neurology and Neurosurgery, Brain Center Rudolf Magnus (C.S.G., B.H.V., G.J.E.R.), and Department of Radiology (J.W.D.), University Medical Center Utrecht, Utrecht University, the Netherlands; Department of Critical Care, University Medical Center Groningen, University of Groningen, the Netherlands (W.M.v.d.B.); Department of Intensive Care and Erasmus MC Stroke Center, Erasmus MC University Medical Center, Rotterdam, the Netherlands (M.v.d.J.); Department of Intensive Care, Academic Medical Center Amsterdam, University of Amsterdam, the Netherlands (M.C.M.); and Department of Intensive Care, Elisabeth-TweeSteden Hospital (ETZ), Tilburg, the Netherlands (A.W.O.)., Müller MC; From the Department of Intensive Care Medicine, Brain Center Rudolf Magnus (C.S.G., A.J.C.S.), Department of Neurology and Neurosurgery, Brain Center Rudolf Magnus (C.S.G., B.H.V., G.J.E.R.), and Department of Radiology (J.W.D.), University Medical Center Utrecht, Utrecht University, the Netherlands; Department of Critical Care, University Medical Center Groningen, University of Groningen, the Netherlands (W.M.v.d.B.); Department of Intensive Care and Erasmus MC Stroke Center, Erasmus MC University Medical Center, Rotterdam, the Netherlands (M.v.d.J.); Department of Intensive Care, Academic Medical Center Amsterdam, University of Amsterdam, the Netherlands (M.C.M.); and Department of Intensive Care, Elisabeth-TweeSteden Hospital (ETZ), Tilburg, the Netherlands (A.W.O.)., Oldenbeuving AW; From the Department of Intensive Care Medicine, Brain Center Rudolf Magnus (C.S.G., A.J.C.S.), Department of Neurology and Neurosurgery, Brain Center Rudolf Magnus (C.S.G., B.H.V., G.J.E.R.), and Department of Radiology (J.W.D.), University Medical Center Utrecht, Utrecht University, the Netherlands; Department of Critical Care, University Medical Center Groningen, University of Groningen, the Netherlands (W.M.v.d.B.); Department of Intensive Care and Erasmus MC Stroke Center, Erasmus MC University Medical Center, Rotterdam, the Netherlands (M.v.d.J.); Department of Intensive Care, Academic Medical Center Amsterdam, University of Amsterdam, the Netherlands (M.C.M.); and Department of Intensive Care, Elisabeth-TweeSteden Hospital (ETZ), Tilburg, the Netherlands (A.W.O.)., Rinkel GJE; From the Department of Intensive Care Medicine, Brain Center Rudolf Magnus (C.S.G., A.J.C.S.), Department of Neurology and Neurosurgery, Brain Center Rudolf Magnus (C.S.G., B.H.V., G.J.E.R.), and Department of Radiology (J.W.D.), University Medical Center Utrecht, Utrecht University, the Netherlands; Department of Critical Care, University Medical Center Groningen, University of Groningen, the Netherlands (W.M.v.d.B.); Department of Intensive Care and Erasmus MC Stroke Center, Erasmus MC University Medical Center, Rotterdam, the Netherlands (M.v.d.J.); Department of Intensive Care, Academic Medical Center Amsterdam, University of Amsterdam, the Netherlands (M.C.M.); and Department of Intensive Care, Elisabeth-TweeSteden Hospital (ETZ), Tilburg, the Netherlands (A.W.O.)., Slooter AJC; From the Department of Intensive Care Medicine, Brain Center Rudolf Magnus (C.S.G., A.J.C.S.), Department of Neurology and Neurosurgery, Brain Center Rudolf Magnus (C.S.G., B.H.V., G.J.E.R.), and Department of Radiology (J.W.D.), University Medical Center Utrecht, Utrecht University, the Netherlands; Department of Critical Care, University Medical Center Groningen, University of Groningen, the Netherlands (W.M.v.d.B.); Department of Intensive Care and Erasmus MC Stroke Center, Erasmus MC University Medical Center, Rotterdam, the Netherlands (M.v.d.J.); Department of Intensive Care, Academic Medical Center Amsterdam, University of Amsterdam, the Netherlands (M.C.M.); and Department of Intensive Care, Elisabeth-TweeSteden Hospital (ETZ), Tilburg, the Netherlands (A.W.O.).
Jazyk: angličtina
Zdroj: Stroke [Stroke] 2018 Jan; Vol. 49 (1), pp. 76-83. Date of Electronic Publication: 2017 Nov 20.
DOI: 10.1161/STROKEAHA.117.017956
Abstrakt: Background and Purpose: Induced hypertension is widely used to treat delayed cerebral ischemia (DCI) after aneurysmal subarachnoid hemorrhage, but a literature review shows that its presumed effectiveness is based on uncontrolled case-series only. We here report clinical outcome of aneurysmal subarachnoid hemorrhage patients with DCI included in a randomized trial on the effectiveness of induced hypertension.
Methods: Aneurysmal subarachnoid hemorrhage patients with clinical symptoms of DCI were randomized to induced hypertension or no induced hypertension. Risk ratios for poor outcome (modified Rankin Scale score >3) at 3 months, with 95% confidence intervals, were calculated and adjusted for age, clinical condition at admission and at time of DCI, and amount of blood on initial computed tomographic scan with Poisson regression analysis.
Results: The trial aiming to include 240 patients was ended, based on lack of effect on cerebral perfusion and slow recruitment, when 21 patients had been randomized to induced hypertension, and 20 patients to no hypertension. With induced hypertension, the adjusted risk ratio for poor outcome was 1.0 (95% confidence interval, 0.6-1.8) and the risk ratio for serious adverse events 2.1 (95% confidence interval, 0.9-5.0).
Conclusions: Before this trial, the effectiveness of induced hypertension for DCI in aneurysmal subarachnoid hemorrhage patients was unknown because current literature consists only of uncontrolled case series. The results from our premature halted trial do not add any evidence to support induced hypertension and show that this treatment can lead to serious adverse events.
Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01613235.
(© 2017 American Heart Association, Inc.)
Databáze: MEDLINE