HaemoAdsorption Nach Reanimation An ECMO

Universitätsklinikum Hamburg-Eppendorf2 个研究点分布在 1 个国家目标入组 40 人开始时间: 2018年10月最近更新: 2018年8月16日

适应症

干预措施

试验速览

阶段: 不适用
发起方: Universitätsklinikum Hamburg-Eppendorf
入组人数: 40
试验地点: 2
主要终点: TNF-a at hour 72

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study evaluates the use of an additional hemoadsorption device in adult patients undergoing veno-arterial extracorporal membrane oxygenation (ECMO) following cardiac arrest and cardiopulmonary resuscitation in respect to its effects on post resuscitation inflammatory syndrome.

At implantation of the ECMO the participants are going to be randomized into a treatment and a control group. The first will be outfitted with a polymer-based adsorption device implemented in the extracorporal circulation established by ECMO for 48h, the control group is going to be treated by ECMO and standard intensive care alone. To detect any significant differences in terms of inflammatory response and patient outcome the investigators will regularly determine the blood levels of certain cytokines in fixed intervalls. In addition, the investigators are going to compare secondary clinical outcome parameters like organ disfunction and 30d mortality.

详细描述

Even after successful return of spontaneus circulation (ROSC), patients suffering a cardiac arrest with subsequent cardipulmonary resuscitation (CPR) are still facing a significant morbidity and mortality in the post-resuscitation phase. They are nowadays often subjected to extracorporal membrane oxygenation (ECMO), supplementing or even replacing cardiac and/or pulmonary function for a certain period in order to reduce the workload for these critical organs. However, as well as the initial ischemia/reperfusion damage, subsequent procedures create significant stress to the patients organism, causing severe inflammation and contributing to post-resuscitation single or multiple organ disfunction and/or failure.

Continously eliminating relevant mediators of inflammation by adsorption to a polymer-based material in extracorporal circulation has been shown to influence the course of this inflammatory syndrome in patients with severe infection and sepsis. Any relevant clinical studies evaluating the use of such a device in post-resuscitation care are still lacking, yet.

Therefore, in this study the investigators are going to test the hypothesis that such a device is capable of significantly altering the cytokine levels during and even shortly after a 48h treatment period in addition to the standard ECMO therapy all patients are going to receive. As a secondary outlook, the investigators are going to compare the clinical outcome of the patients in terms of major organ disfunction and overall 30d mortality.

At the time extracoporal circulation is established during or after CPR, all participants (n=40) are enrolled and randomized into a treatment and a control group. The extracorporal circulation over the ECMO device is then outfitted with a certified in line adsorption cartridge for the treatment group. Due to technical reasons, this cartridge has to be exchanged for another identical module after 24h of continuous treatment. Adsorption therapy is terminated after 48h. The control group is subjected to ECMO without any additional modules. Both groups are receiving standard intensive care during the course of the study. All diagnostic and therapeutic decisions with the exemption of those directly concerning the hemoadsorption and sampling protocol are at sole discretion of the clinical staff.

For both groups, blood samples are taken at time points 0,6,12,24,36,48,72h after establishment of ECMO or time of death, respectively. Relevant parameters are then determined in different diagnostic and research laboratories with/without sample preprocessing by the study personal in accordance with preanalytic requirements. All relevant clinical data is extracted from the digital patient data management system (PDMS).

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

盲法说明

Participants are regularily going to be unconsciuos during the differential treatment phase due to the nature and severity of their condition, yet exceptions to this are not going to be suppressed for obvious ethical reasons.

入排标准

年龄范围: 18 Years 至 75 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•observed cardiac arrest with initial hyperdynamic rhythm and sufficient primary resuscitation
•Exclusion Criteria (absolute):
•existing "do-not-resuscitate"-order from the patient/a priori palliative situation
•severe trauma
•severe acute bleeding due to any cause
•confirmed or highly likely relevant and severe persistent neurologic impairment
•severe limiting comorbidities with independent and relevant reduction of life expectancy (e.g. malignoma, preexistent heart failure syndrome, obstructive/restrictive lung disease, hepatic cirrhosis)
•Exclusion Criteria (relative, at the discretion of the responsible provider):
•severe initial lacacidosis
•prolongued mechanical resuscitation (>30min)

排除标准

未提供

研究组 & 干预措施

Treatment

Experimental

Inclusion of an extracorporal in line adsorbing cartridge for 48h (with a cartridge exchange at 24h) post establishing ECMO in addition to standard post resuscitation intensive care

干预措施: Hemoadsorption (Device)

Control

No Intervention

ECMO and standard post resuscitation intensive care without any additional module in extracorporal circulation

结局指标

主要结局

TNF-a at hour 72

时间窗: 72 hours post establishment of extracorporal membrane oxygenation (ECMO)

Blood levels of human tumor necrosis factor alpha will be compared between intervention and control group

IL-6 at hour 6

时间窗: 6 hours post establishment of extracorporal membrane oxygenation (ECMO)