TY - JOUR
T1 - Randomized pilot trial of intensive management of blood pressure or volume expansion in subarachnoid hemorrhage (improves)
AU - Togashi, Kei
AU - Joffe, Aaron M.
AU - Sekhar, Laligam
AU - Kim, Louis
AU - Lam, Arthur
AU - Yanez, David
AU - Broeckel-Elrod, Jo Ann
AU - Moore, Anne
AU - Deem, Steve
AU - Khandelwal, Nita
AU - Souter, Michael J.
AU - Treggiari, Miriam M.
N1 - Publisher Copyright:
Copyright © 2014 by the Congress of Neurological Surgeons. Copyright © 2014 by the Congress of Neurological Surgeons.
PY - 2015
Y1 - 2015
N2 - BACKGROUND: Volume expansion and hypertension are widely used for the hemodynamic management of patients with subarachnoid hemorrhage. OBJECTIVE: To investigate the feasibility, adherence, and retention in a trial of volume expansion and blood pressure manipulation to prevent delayed cerebral ischemia. METHODS: A randomized pilot trial using a 2-way factorial design allocating patients within 72 hours of subarachnoid hemorrhage to either normovolemia (NV) or volume expansion (HV) and simultaneously to conventional (CBP) or augmented blood pressure (ABP) for 10 days. The study endpoints were protocol adherence and retention to follow-up. The quality of endpoints for a larger trial were 6-month modified Rankin Scale score, comprehensive neurobehavioral assessment, delayed cerebral ischemia, new stroke, and discharge disposition. RESULTS: Twenty patients were randomized and completed follow-up. The overall difference in daily mean intravenous fluid intake was 2099 mL (95% confidence interval [CI]: 867, 3333), HV vs NV group. The overall mean systolic blood pressure difference was 5 mm Hg (95% CI: 24.65, 14.75), ABP vs CBP group. Adverse events included death (n = 1), delayed cerebral ischemia (n = 1), and pulmonary complications (n = 3). There were no differences in modified Rankin Scale score between HV and NV (difference 0.1; 95% CI:21.26, 1.46, P = .87) or between ABP and CBP groups (20.5, 95% CI:21.78, 0.78, P = .43). Neuropsychological scores were similar between HV vs NV, but tended to be worse in ABP (576 27) vs CBP group (85 6 21, P = .04). CONCLUSION: This pilot study showed adequate feasibility and excellent retention to followup. Given the suggestion of possible worse neurobehavioral outcome with ABP, a larger trial to determine the optimal blood pressure management in this patient population is warranted. (ClinTrials.gov NCT01414894.).
AB - BACKGROUND: Volume expansion and hypertension are widely used for the hemodynamic management of patients with subarachnoid hemorrhage. OBJECTIVE: To investigate the feasibility, adherence, and retention in a trial of volume expansion and blood pressure manipulation to prevent delayed cerebral ischemia. METHODS: A randomized pilot trial using a 2-way factorial design allocating patients within 72 hours of subarachnoid hemorrhage to either normovolemia (NV) or volume expansion (HV) and simultaneously to conventional (CBP) or augmented blood pressure (ABP) for 10 days. The study endpoints were protocol adherence and retention to follow-up. The quality of endpoints for a larger trial were 6-month modified Rankin Scale score, comprehensive neurobehavioral assessment, delayed cerebral ischemia, new stroke, and discharge disposition. RESULTS: Twenty patients were randomized and completed follow-up. The overall difference in daily mean intravenous fluid intake was 2099 mL (95% confidence interval [CI]: 867, 3333), HV vs NV group. The overall mean systolic blood pressure difference was 5 mm Hg (95% CI: 24.65, 14.75), ABP vs CBP group. Adverse events included death (n = 1), delayed cerebral ischemia (n = 1), and pulmonary complications (n = 3). There were no differences in modified Rankin Scale score between HV and NV (difference 0.1; 95% CI:21.26, 1.46, P = .87) or between ABP and CBP groups (20.5, 95% CI:21.78, 0.78, P = .43). Neuropsychological scores were similar between HV vs NV, but tended to be worse in ABP (576 27) vs CBP group (85 6 21, P = .04). CONCLUSION: This pilot study showed adequate feasibility and excellent retention to followup. Given the suggestion of possible worse neurobehavioral outcome with ABP, a larger trial to determine the optimal blood pressure management in this patient population is warranted. (ClinTrials.gov NCT01414894.).
KW - Behavior mechanisms
KW - Cerebral vasospasm
KW - Critical care
KW - Delayed ischemic neurological deficits
KW - Hypertension
KW - Hypervolemia
KW - Triple H therapy
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U2 - 10.1227/NEU.0000000000000592
DO - 10.1227/NEU.0000000000000592
M3 - Article
C2 - 25549192
AN - SCOPUS:84925969808
SN - 0148-396X
VL - 76
SP - 125
EP - 134
JO - Neurosurgery
JF - Neurosurgery
IS - 2
ER -