Pilot Study of Hemofiltration after Out-of-Hospital Cardiac Arrest

项目摘要/摘要 可行性本研究将评估招募符合条件的患者(PTS)的可行性，以及纳入的PTS的可行性。 接受低容量或高容量血液滤过(HF)的患者中，48小时内至少80% 从院外心脏骤停(OuchA)复苏。HF洗涤血液以去除血液 炎症因子与再灌注损伤(RI)、器官功能障碍和死亡相关。 背景阻力发生在OuchA后的循环恢复期间。它与实质性的释放有关 致炎细胞因子的作用。这会导致24小时内的微循环功能障碍。心功能 在接下来的三天里，情况有所改善，但血管通透性增加，容易造成神经损伤， 多器官功能障碍和死亡。HF是一种去除细胞外液的技术，类似于 血液透析。这种细胞外液包括含有释放的炎症因子的溶质。 在国际扶轮期间。我们建议评估使用HF技术的可行性(Diapact，B Braun Medical Inc.， 从CA复苏后减少RI。方法设计--个体随机试验。 人群-成人OuchA后有任何初始节律的自发循环。排除：请勿尝试 复苏命令；严重的停搏前神经功能障碍；昏迷的另一个原因；迟钝， 穿透或其他损伤；血小板减少或凝血障碍；下腔静脉滤器原位；已知 妊娠；血流动力学不稳定；对乙酰氨基酚过敏；事先参加研究。干预措施- 随机分为对照组、低剂量HF组和高容量HF组，持续48小时。控制和干预PTS应 根据需要接受静脉输液、血管增压剂或血管扩张剂治疗以维持中心静脉 血压8-12毫米汞柱，平均动脉压在100-120毫米汞柱之间。并发干预将 包括在昏迷病人中开始和维持治疗性低温。分析-- 符合条件的入选患者和48小时内接受至少80%心力衰竭的干预患者的比例 将被概括为二项式比例。临床措施将进行描述性总结。样本量- 我们预计，在12个月的注册期间，将有大约60分符合我们的纳入标准。我们会 报名30分(每组10分)。相关性这项试验将证明HF在从OuchA复苏的PTS中是可行的。 一项后续试验的设计，以测试HF对生存、神经功能和健康相关的影响 生活质量将根据这项初步研究的结果进行修改。

Project Summary/Abstract Feasibility This study will assess the feasibility of enrolling eligible patients (pts), and of enrolled pts undergoing low-volume or high-volume hemofiltration (HF) for at least 80% of 48 hours among those resuscitated from out-of-hospital cardiac arrest (OOHCA). HF washes the blood to remove the blood inflammatory factors that are associated with reperfusion injury (RI), organ dysfunction and death. Background RI occurs during restoration of circulation after OOHCA. It is associated with substantial release of pro-inflammatory cytokines. This leads to microcirculatory dysfunction within 24 hours. Cardiac function improves but vascular permeability increase over the next three days, predisposing to neurologic injury, multiple organ dysfunction and death. HF is a technique of removing extracellular fluid that is similar to hemodialysis. This extracellular fluid includes the solutes, which contain the inflammatory factors released during RI. We propose to evaluate the feasibility of using HF technology (Diapact, B Braun Medical Inc., Bethlehem, PA) to reduce RI after resuscitation from CA. Methods Design- Individual randomized trial. Population- Adults with spontaneous circulation after OOHCA with any initial rhythm. Excluded: do not attempt resuscitation orders; major pre-arrest neurological dysfunction; another reason to be comatose; blunt, penetrating or other injury; thrombocytopenia or coagulopathy; inferior vena cava filter in situ; known pregnancy; hemodynamic instability; allergy to acetaminophen; prior enrollment in the study. Interventions- randomized to control versus low-HF versus high-volume HF for 48 hours. Control and intervention pts shall receive intravenous fluids, vasopressor or vasodilator treatment as required to maintain a central venous pressure of 8-12 mm Hg and a mean arterial pressure between 100-120 mm Hg. Concurrent intervention will include initiation and maintenance of therapeutic hypothermia in pts who are unconscious. Analyses- The proportion of eligible pts who are enrolled, and of intervention pts who undergo HF for at least 80% of 48 hours will be summarized as binomial proportions. Clinical measures will be summarized descriptively. Sample Size- we anticipate that about 60 pts will meet our inclusion criteria during a 12 month enrollment period. We shall enroll 30 pts (10 per group). Relevance this trial will prove that HF is feasible in pts resuscitated from OOHCA. The design of a subsequent trial to test the effect of HF upon survival, neurologic function and health-related QOL will be modified based on the results of this pilot study.