HaemoAdsorption Nach Reanimation An ECMO

NCT03632837 | Unknown FDA Device

• 1 other identifier: UKEHANRAE
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiac Arrest; Resuscitation; Inflammation; Multi-Organ Disorder

Keywords

extracorporal circulation; hemoadsorption; post resuscitation syndrome

Outcome Measures

Primary Outcomes (10)

• IL-6 at hour 6

  Blood levels of interleukine 6 will be compared between intervention and control group

  6 hours post establishment of extracorporal membrane oxygenation (ECMO)

• IL-6 at hour 12

  Blood levels of interleukine 6 will be compared between intervention and control group

  12 hours post establishment of extracorporal membrane oxygenation (ECMO)

• IL-6 at hour 24

  Blood levels of interleukine 6 will be compared between intervention and control group

  24 hours post establishment of extracorporal membrane oxygenation (ECMO)

• IL-6 at hour 48

  Blood levels of interleukine 6 will be compared between intervention and control group

  48 hours post establishment of extracorporal membrane oxygenation (ECMO)

• IL-6 at hour 72

  Blood levels of interleukine 6 will be compared between intervention and control group

  72 hours post establishment of extracorporal membrane oxygenation (ECMO)

• TNF-a at hour 6

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

  6 hours post establishment of extracorporal membrane oxygenation (ECMO)

• TNF-a at hour 12

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

  12 hours post establishment of extracorporal membrane oxygenation (ECMO)

• TNF-a at hour 24

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

  24 hours post establishment of extracorporal membrane oxygenation (ECMO)

• TNF-a at hour 48

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

  48 hours post establishment of extracorporal membrane oxygenation (ECMO)

• TNF-a at hour 72

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

  72 hours post establishment of extracorporal membrane oxygenation (ECMO)

Secondary Outcomes (43)

• S1P

  at hours 0,6,12,24,48,72 post establishment of extracorporal membrane oxygenation (ECMO)

• PCT

  at hours 0,6,12,24,48,72 post establishment of extracorporal membrane oxygenation (ECMO)

• CRP

  at hours 0,6,12,24,48,72 post establishment of extracorporal membrane oxygenation (ECMO)

• Leukocytes

  at hours 0,6,12,24,48,72 post establishment of extracorporal membrane oxygenation (ECMO)

• BNP

  at hours 0,6,12,24,48,72 post establishment of extracorporal membrane oxygenation (ECMO)

Study Arms (2)

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

Device: Hemoadsorption

Control

NO INTERVENTION

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

Interventions

Hemoadsorption DEVICE

see arm description

Treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• observed cardiac arrest with initial hyperdynamic rhythm and sufficient primary resuscitation

You may not qualify if:

• 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)
• severe initial lacacidosis
• prolongued mechanical resuscitation (\>30min)

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead
• CytoSorbents Corporation and CytoSorbents Medical Inc.: collaborator

Study Sites (1)

University Hospital Hamburg-Eppendorf

Hamburg, 20246, Germany

RECRUITING

Related Publications (6)

• 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.

  PMID: 15166838 BACKGROUND

• 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.

  PMID: 15090965 BACKGROUND

• 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.

  PMID: 18434884 BACKGROUND

• 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.

  PMID: 27079418 BACKGROUND

• 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.

  PMID: 25656010 BACKGROUND

• 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.

  PMID: 27059056 BACKGROUND

MeSH Terms

Conditions

Heart Arrest; Inflammation

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jens Kubitz, Prof. Dr.

  Universitätsklinikum Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jens Kubitz, Prof. Dr.

CONTACT

+49 (0) 40 7410 - 52415; j.kubitz@uke.de

Eike Pfefferkorn, Dr.

CONTACT

e.pfefferkorn@uke.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2018
• First Posted: August 16, 2018
• Study Start: October 1, 2018
• Primary Completion: May 1, 2019
• Study Completion: September 1, 2019
• Last Updated: August 16, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)