Togashi Kei, Joffe Aaron M, Sekhar Laligam, Kim Louis, Lam Arthur, Yanez David, Broeckel-Elrod Jo Ann, Moore Anne, Deem Steve, Khandelwal Nita, Souter Michael J, Treggiari Miriam M
*Department of Anesthesiology and Pain Medicine, University of Washington, Seattle, Washington; ‡Department of Neurological Surgery, University of Washington, Seattle, Washington; §Neuroscience Institute, Swedish Medical Center, Seattle, Washington; ¶Division of Biostatistics, Department of Public Health and Preventive Medicine, Oregon Health and Science University, Portland, Oregon; ‖Department of Anesthesiology and Perioperative Medicine, Oregon Health and Science University, Portland, Oregon.
Neurosurgery. 2015 Feb;76(2):125-34; discussion 134-5; quiz 135. doi: 10.1227/NEU.0000000000000592.
Volume expansion and hypertension are widely used for the hemodynamic management of patients with subarachnoid hemorrhage.
To investigate the feasibility, adherence, and retention in a trial of volume expansion and blood pressure manipulation to prevent delayed cerebral ischemia.
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.
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: -4.65, 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: -1.26, 1.46, P=.87) or between ABP and CBP groups (-0.5, 95% CI: -1.78, 0.78, P=.43). Neuropsychological scores were similar between HV vs NV, but tended to be worse in ABP (57±27) vs CBP group (85±21, P=.04).
This pilot study showed adequate feasibility and excellent retention to follow-up. 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.)
容量扩张和高血压广泛应用于蛛网膜下腔出血患者的血流动力学管理。
探讨容量扩张和血压调控预防迟发性脑缺血试验的可行性、依从性和随访保留率。
采用二因素设计的随机试点试验，在蛛网膜下腔出血72小时内将患者随机分为正常血容量组（NV）或高血容量组（HV），同时分为常规血压组（CBP）或强化血压组（ABP），持续10天。研究终点为方案依从性和随访保留率。大型试验的终点质量指标为6个月改良Rankin量表评分、综合神经行为评估、迟发性脑缺血、新发卒中及出院处置情况。
20例患者被随机分组并完成随访。高血容量组与正常血容量组每日平均静脉补液量总体差异为2099 mL（95%置信区间[CI]：867，3333）。强化血压组与常规血压组总体平均收缩压差异为5 mmHg（95%CI：-4.65，14.75）。不良事件包括死亡（n=1）、迟发性脑缺血（n=1）和肺部并发症（n=3）。高血容量组与正常血容量组之间改良Rankin量表评分无差异（差异为0.1；95%CI：-1.26，1.46，P=0.87），强化血压组与常规血压组之间也无差异（-0.5，95%CI：-1.78，0.78，P=0.43）。高血容量组与正常血容量组之间神经心理学评分相似，但强化血压组（57±27）与常规血压组（85±21，P=0.04）相比倾向于更差。
这项试点研究显示出足够的可行性和出色的随访保留率。鉴于强化血压可能导致更差的神经行为结局，有必要开展一项大型试验以确定该患者群体的最佳血压管理方案。（临床研究注册号：NCT01414894）
