HaemoAdsorption Nach Reanimation An ECMO (HANRAE)

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).