HaemoAdsorption Nach Reanimation An ECMO (HANRAE)

U

Universitätsklinikum Hamburg-Eppendorf

Status

Unknown

Conditions

Inflammation
Multi-Organ Disorder
Cardiac Arrest
Resuscitation

Treatments

Device: Hemoadsorption

Study type

Interventional

Funder types

Other

Identifiers

NCT03632837
UKEHANRAE

Details and patient eligibility

About

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.

Full description

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).

Enrollment

40 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

All patients receiving a veno-arterial ECMO after cardiac arrest at the study site are eligible for the study. Thus, the criteria are defined by the SOP "ECMO bei Reanimation" of the University Heart Center Hamburg: Inclusion Criteria: * 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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

Treatment
Experimental group
Description:
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
Treatment:
Device: Hemoadsorption
Control
No Intervention group
Description:
ECMO and standard post resuscitation intensive care without any additional module in extracorporal circulation

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Jens Kubitz, Prof. Dr.; Eike Pfefferkorn, Dr.

Data sourced from clinicaltrials.gov

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