TY - JOUR
T1 - Induced Hypertension for Delayed Cerebral Ischemia After Aneurysmal Subarachnoid Hemorrhage
T2 - A Randomized Clinical Trial
AU - HIMALAIA Study Group
AU - Gathier, Celine S
AU - van den Bergh, Walter M
AU - van der Jagt, Mathieu
AU - Verweij, Bon H
AU - Dankbaar, Jan Willem
AU - Müller, Marcella C
AU - Oldenbeuving, Annemarie W
AU - Rinkel, Gabriel J E
AU - Slooter, Arjen J C
AU - AUTHOR GROUP
AU - Algra, Ale
AU - Kesecioglu, Jozef
AU - van der Schaaf, Irene C.
AU - Dammers, Ruben
AU - Dippel, Diederik W. J.
AU - Dirven, Clemens M. F.
AU - van Kooten, Fop
AU - van der Lugt, Aad
AU - Coert, Bert A.
AU - Horn, Janneke
AU - Vandertop, W. Peter
AU - Beute, Gus N.
AU - van der Pol, Bram
AU - Roks, Gerwin
AU - van Rooij, Willem Jan J.
AU - Sluzewski, Menno
PY - 2018/1
Y1 - 2018/1
N2 - 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.
AB - 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.
KW - Adult
KW - Aged
KW - Brain Ischemia/physiopathology
KW - Case-Control Studies
KW - Female
KW - Humans
KW - Hypertension
KW - Intracranial Aneurysm/diagnostic imaging
KW - Male
KW - Middle Aged
KW - Subarachnoid Hemorrhage/diagnostic imaging
KW - Tomography, X-Ray Computed
U2 - https://doi.org/10.1161/STROKEAHA.117.017956
DO - https://doi.org/10.1161/STROKEAHA.117.017956
M3 - Article
C2 - 29158449
SN - 0039-2499
VL - 49
SP - 76
EP - 83
JO - Stroke
JF - Stroke
IS - 1
ER -