Celine S Gathier1, Walter M van den Bergh2, Mathieu van der Jagt2, Bon H Verweij2, Jan Willem Dankbaar2, Marcella C Müller2, Annemarie W Oldenbeuving2, Gabriel J E Rinkel2, Arjen J C Slooter2. 1. 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. 2. 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.).
Abstract
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.
RCT Entities:
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 hemorrhagepatients with DCI included in a randomized trial on the effectiveness of induced hypertension. METHODS:Aneurysmal subarachnoid hemorrhagepatients 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 hemorrhagepatients 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.
Authors: C J Reuß; M Bernhard; C Beynon; A Hecker; C Jungk; C Nusshag; M A Weigand; D Michalski; T Brenner Journal: Anaesthesist Date: 2018-09 Impact factor: 1.041
Authors: Joseph R Geraghty; Melissa N Lara-Angulo; Milen Spegar; Jenna Reeh; Fernando D Testai Journal: J Stroke Cerebrovasc Dis Date: 2020-06-20 Impact factor: 2.136
Authors: Mendel Castle-Kirszbaum; Leon Lai; Julian Maingard; Hamed Asadi; R Andrew Danks; Tony Goldschlager; Ronil V Chandra Journal: Neurosurg Rev Date: 2021-03-08 Impact factor: 3.042
Authors: Levin Häni; Mario D Ropelato; Franca Wagner; Andreas Nowacki; Nicole Söll; Matthias Haenggi; Andreas Raabe; Werner J Z'Graggen Journal: Neurocrit Care Date: 2020-12-16 Impact factor: 3.210
Authors: Sean N Neifert; Emily K Chapman; Michael L Martini; William H Shuman; Alexander J Schupper; Eric K Oermann; J Mocco; R Loch Macdonald Journal: Transl Stroke Res Date: 2020-10-19 Impact factor: 6.829