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

描述（由申请人提供）：本研究将评估纳入符合条件的患者（pts）的可行性，以及在院外心脏骤停（OOHCA）复苏的患者中接受低容量或高容量血液滤过（HF）至少48小时80%的入组患者的可行性。心衰冲洗血液以清除与再灌注损伤（RI）、器官功能障碍和死亡相关的血液炎症因子。背景：在OOHCA后循环恢复期间发生RI。它与促炎细胞因子的大量释放有关。这会在24小时内导致微循环功能障碍。心脏功能改善，但血管通透性在接下来的三天内增加，易发生神经损伤、多器官功能障碍和死亡。HF是一种清除细胞外液的技术，类似于血液透析。这种细胞外液包括溶质，其中含有RI期间释放的炎症因子。我们建议评估使用HF技术（Diapact, B Braun Medical Inc., Bethlehem， PA）降低CA复苏后RI的可行性。方法设计-个体随机试验。人群- OOHCA后有任何初始心律的自发循环的成年人。排除：不尝试复苏指令；严重的骤停前神经功能障碍；另一个昏迷的原因；钝的、穿透的或其他伤害；血小板减少或凝血功能障碍；下腔静脉原位过滤器；已知怀孕;血流动力学不稳定;对扑热息痛过敏；参加研究之前。干预措施：随机分为对照组、低容量HF组和高容量HF组，治疗48小时。对照和干预患者应接受静脉输液、血管加压或血管扩张剂治疗，以维持中心静脉压8- 12mmhg，平均动脉压在100- 120mmhg之间。同时进行的干预包括开始和维持无意识患者的治疗性低温。分析-纳入的符合条件的患者的比例，以及48小时中至少80%发生HF的干预患者的比例将总结为二项比例。将描述性地总结临床措施。样本量-我们预计在12个月的登记期内约有60名患者符合我们的纳入标准。我们将招募30名患者（每组10名）。本试验将证明心力衰竭在OOHCA复苏的患者中是可行的。后续试验的设计，以测试HF对生存、神经功能和健康相关生活质量的影响，将根据该初步研究的结果进行修改。公共卫生相关性：由于血流恢复时细胞释放的循环因子引起的炎症，大多数最初从心脏骤停复苏的患者不能存活到出院。血液滤过从血液中去除这些与器官功能障碍和死亡有关的炎症因子。我们将测试使用血液滤过治疗心脏骤停患者是否可行。

DESCRIPTION (provided by applicant): 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. PUBLIC HEALTH RELEVANCE: Most patients initially resuscitated from cardiac arrest do not survive to hospital discharge because of inflammation caused by circulating factors that are released by cells when blood flow is restored. Hemofiltration removes from the blood these inflammatory factors that are associated with organ dysfunction and death. We will test whether it is feasible to use hemofiltration to treat patients who have had cardiac arrest.