Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2018-10-31
2019-09-30
Brief Summary
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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.
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Treatment
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
Hemoadsorption
see arm description
Control
ECMO and standard post resuscitation intensive care without any additional module in extracorporal circulation
No interventions assigned to this group
Interventions
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Hemoadsorption
see arm description
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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)
* severe initial lacacidosis
* prolongued mechanical resuscitation (\>30min)
18 Years
75 Years
ALL
No
Sponsors
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CytoSorbents Corporation and CytoSorbents Medical Inc.
UNKNOWN
Universitätsklinikum Hamburg-Eppendorf
OTHER
Responsible Party
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Principal Investigators
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Jens Kubitz, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Universitätsklinikum Hamburg-Eppendorf
Locations
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University Hospital Hamburg-Eppendorf
Hamburg, , Germany
Countries
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Central Contacts
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Facility Contacts
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References
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Adrie C, Laurent I, Monchi M, Cariou A, Dhainaou JF, Spaulding C. Postresuscitation disease after cardiac arrest: a sepsis-like syndrome? Curr Opin Crit Care. 2004 Jun;10(3):208-12. doi: 10.1097/01.ccx.0000126090.06275.fe.
Kellum JA, Song M, Venkataraman R. Hemoadsorption removes tumor necrosis factor, interleukin-6, and interleukin-10, reduces nuclear factor-kappaB DNA binding, and improves short-term survival in lethal endotoxemia. Crit Care Med. 2004 Mar;32(3):801-5. doi: 10.1097/01.ccm.0000114997.39857.69.
Peng ZY, Carter MJ, Kellum JA. Effects of hemoadsorption on cytokine removal and short-term survival in septic rats. Crit Care Med. 2008 May;36(5):1573-7. doi: 10.1097/CCM.0b013e318170b9a7.
Tomescu DR, Olimpia Dima S, Ungureanu D, Popescu M, Tulbure D, Popescu I. First report of cytokine removal using CytoSorb(R) in severe noninfectious inflammatory syndrome after liver transplantation. Int J Artif Organs. 2016 May 16;39(3):136-40. doi: 10.5301/ijao.5000489. Epub 2016 Apr 14.
Bruenger F, Kizner L, Weile J, Morshuis M, Gummert JF. First successful combination of ECMO with cytokine removal therapy in cardiogenic septic shock: a case report. Int J Artif Organs. 2015 Feb;38(2):113-6. doi: 10.5301/ijao.5000382. Epub 2015 Feb 3.
Bernardi MH, Rinoesl H, Dragosits K, Ristl R, Hoffelner F, Opfermann P, Lamm C, Preissing F, Wiedemann D, Hiesmayr MJ, Spittler A. Effect of hemoadsorption during cardiopulmonary bypass surgery - a blinded, randomized, controlled pilot study using a novel adsorbent. Crit Care. 2016 Apr 9;20:96. doi: 10.1186/s13054-016-1270-0.
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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UKEHANRAE
Identifier Type: -
Identifier Source: org_study_id
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