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

院外心脏骤停后血液滤过的初步研究

• 批准号: 7923218
• 负责人: Graham Nichol
• 金额: $ 19.5万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-01 至 2014-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7923218
• 关键词: Acetaminophen; Adult; Blood; Blood Circulation; Blood Coagulation Disorders; Blood flow; Cardiac; Cells; Central venous pressure; Cessation of life; Clinical; Coma; Confidence Intervals; Effectiveness; Enrollment; Extracellular Fluid; Functional disorder; Future; Health; Heart Arrest; Hemodialysis; Hemofiltration; Hospitals; Hour; Hypersensitivity; IV Fluid; In Situ; Individual; Inflammation; Inflammatory; Injury; Intervention; Maintenance; Measures; Medical; Methods; Morbidity - disease rate; Multiple Trauma; Nervous System Physiology; Neurologic; Neurologic Dysfunctions; Organ; Outcome; Patients; Pilot Projects; Population; Pregnancy; Process; Quality of life; Randomized; Reperfusion Injury; Resuscitation; Resuscitation Orders; Safety; Sample Size; Techniques; Technology; Testing; Therapeutic; Thrombocytopenia; Unconscious State; Vascular Permeabilities; Vasoconstrictor Agents; Vasodilator Agents; Vena Cava Filters; abstracting; base; cytokine; design; health related quality of life; hemodynamics; improved; improved functioning; inclusion criteria; meetings; natural hypothermia; pressure; randomized trial; release factor; restoration; solute; standard care

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.

项目总结/摘要 可行性本研究将评估入组合格患者（pts）和入组患者的可行性 在接受低容量或高容量血液滤过（HF）至少80%的48小时的患者中， 从院外心脏骤停（OOHCA）中复苏。HF清洗血液以去除血液 与再灌注损伤（RI）、器官功能障碍和死亡相关的炎性因子。 背景RI发生在OOHCA后循环恢复期间。它与大量释放有关， 促炎性细胞因子这会在24小时内导致微循环功能障碍。心功能 改善，但在接下来的三天内血管渗透性增加，易导致神经损伤， 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，其含有释放的炎症因子 在RI期间。我们建议评估使用HF技术的可行性（Diapact，B Braun Medical Inc.， Bethlehem，PA）以降低CA复苏后的RI。方法设计-个体随机试验。 人群-OOHCA后具有任何初始心律的自主循环的成人。排除：请勿尝试 复苏命令;主要的预逮捕神经功能障碍;另一个昏迷的原因;钝， 穿透性或其他损伤;血小板减少症或凝血功能障碍;原位下腔静脉滤器;已知 妊娠;血流动力学不稳定;对乙酰氨基酚过敏;既往入组研究。干预- 随机分为对照组与低HF组与高容量HF组，持续48小时。控制和干预患者应 根据需要接受静脉输液、血管加压剂或血管扩张剂治疗，以维持中心静脉 血压为8-12 mm Hg，平均动脉压为100-120 mm Hg。同时进行的干预将 包括在无意识患者中开始和维持治疗性低温。分析- The 入组的合格患者比例和48小时内至少80%发生HF的干预患者比例 将以二项比例进行总结。将对临床指标进行总结。样本量- 我们预计在12个月的招募期内约有60名患者符合我们的入选标准。我们将 入组30例患者（每组10例）。相关性本试验将证明HF在从OOHCA复苏的患者中是可行的。 设计一项后续试验，以测试HF对生存、神经功能和健康相关性的影响。 将根据本初步研究的结果修改QOL。