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HaemoAdsorption Nach Reanimation An ECMO (HANRAE)

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ClinicalTrials.gov Identifier: NCT03632837
Recruitment Status : Recruiting
First Posted : August 16, 2018
Last Update Posted : August 16, 2018
Sponsor:
Collaborator:
CytoSorbents Corporation and CytoSorbents Medical Inc.
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf

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.


Condition or disease Intervention/treatment Phase
Cardiac Arrest Resuscitation Inflammation Multi-Organ Disorder Device: Hemoadsorption Not Applicable

Detailed 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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: HaemoAdsorption Nach Reanimation An ECMO
Estimated Study Start Date : October 2018
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : September 2019

Arm Intervention/treatment
Experimental: 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
Device: Hemoadsorption
see arm description

No Intervention: Control
ECMO and standard post resuscitation intensive care without any additional module in extracorporal circulation



Primary Outcome Measures :
  1. IL-6 at hour 6 [ Time Frame: 6 hours post establishment of extracorporal membrane oxygenation (ECMO) ]
    Blood levels of interleukine 6 will be compared between intervention and control group

  2. IL-6 at hour 12 [ Time Frame: 12 hours post establishment of extracorporal membrane oxygenation (ECMO) ]
    Blood levels of interleukine 6 will be compared between intervention and control group

  3. IL-6 at hour 24 [ Time Frame: 24 hours post establishment of extracorporal membrane oxygenation (ECMO) ]
    Blood levels of interleukine 6 will be compared between intervention and control group

  4. IL-6 at hour 48 [ Time Frame: 48 hours post establishment of extracorporal membrane oxygenation (ECMO) ]
    Blood levels of interleukine 6 will be compared between intervention and control group

  5. IL-6 at hour 72 [ Time Frame: 72 hours post establishment of extracorporal membrane oxygenation (ECMO) ]
    Blood levels of interleukine 6 will be compared between intervention and control group

  6. TNF-a at hour 6 [ Time Frame: 6 hours post establishment of extracorporal membrane oxygenation (ECMO) ]
    Blood levels of human tumor necrosis factor alpha will be compared between intervention and control group

  7. TNF-a at hour 12 [ Time Frame: 12 hours post establishment of extracorporal membrane oxygenation (ECMO) ]
    Blood levels of human tumor necrosis factor alpha will be compared between intervention and control group

  8. TNF-a at hour 24 [ Time Frame: 24 hours post establishment of extracorporal membrane oxygenation (ECMO) ]
    Blood levels of human tumor necrosis factor alpha will be compared between intervention and control group

  9. TNF-a at hour 48 [ Time Frame: 48 hours post establishment of extracorporal membrane oxygenation (ECMO) ]
    Blood levels of human tumor necrosis factor alpha will be compared between intervention and control group

  10. TNF-a at hour 72 [ Time Frame: 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


Secondary Outcome Measures :
  1. S1P [ Time Frame: at hours 0,6,12,24,48,72 post establishment of extracorporal membrane oxygenation (ECMO) ]
    Blood levels of sphingosine-1-phosphate will be compared between intervention and control group.

  2. PCT [ Time Frame: at hours 0,6,12,24,48,72 post establishment of extracorporal membrane oxygenation (ECMO) ]
    The serum levels of procalcitonine will be compared between intervention and control group.

  3. CRP [ Time Frame: at hours 0,6,12,24,48,72 post establishment of extracorporal membrane oxygenation (ECMO) ]
    The plasma levels of C-related peptide will be compared between intervention and control group.

  4. Leukocytes [ Time Frame: at hours 0,6,12,24,48,72 post establishment of extracorporal membrane oxygenation (ECMO) ]
    The number of leukocytes in simple blood count will be compared between intervention and control group.

  5. BNP [ Time Frame: at hours 0,6,12,24,48,72 post establishment of extracorporal membrane oxygenation (ECMO) ]
    The serum levels of n-terminal pro brain natriuretic peptide will be compared between intervention and control group.

  6. Mean arterial pressure (MAP) [ Time Frame: Continuosly from enrollment to 72h post. ]
    The mean arterial pressure as calculated automatically from the invasively measured arterial pressure curve will be compared between intervention and control group.

  7. Heart rate (HR) [ Time Frame: Continuosly from enrollment to 72h post. ]
    The continuously monitored heart rate will be compared between intervention and control group.

  8. Central venous pressure (CVP) [ Time Frame: Continuosly from enrollment to 72h post. ]
    The continuously and invasively measured mean central venous pressure will be compared between intervention and control group, if available.

  9. haemodynamically relevant medication [ Time Frame: Continuosly from enrollment to 72h post. ]
    The continuous intake of the following drugs as chosen by discretion of the clinical staff is extracted from digital PDMS: Norepinephrine, Epinephrine, Dobutamin, inodilatators (Milrinon, Enoximon, Levosimendan)

  10. Trop [ Time Frame: at hours 0,6,12,24,48,72 post establishment of extracorporal membrane oxygenation (ECMO) ]
    The serum levels of troponine T will be compared between intervention and control group

  11. CK [ Time Frame: at hours 0,6,12,24,48,72 post establishment of extracorporal membrane oxygenation (ECMO) ]
    The Plasma levels of creatinkinase will be compared between intervention and control group.

  12. Myoglobine [ Time Frame: at hours 0,6,12,24,48,72 post establishment of extracorporal membrane oxygenation (ECMO) ]
    The Serum levels of myoglobine will be compared between intervention and control group.

  13. Hemoglobine [ Time Frame: at hours 0,6,12,24,48,72 post establishment of extracorporal membrane oxygenation (ECMO) ]
    The total blood concentration of hemoglobine will be compared between intervention and control group.

  14. Haptoglobine [ Time Frame: at hours 0,6,12,24,48,72 post establishment of extracorporal membrane oxygenation (ECMO) ]
    The serum levels of haptoglobine will be compared between intervention and control group.

  15. paO2 [ Time Frame: at hours 0,6,12,24,48,72 post establishment of extracorporal membrane oxygenation (ECMO) ]
    The arterial partial pressure of oxygen as measured by point-of-care blood gas analysis is going to be compared between intervention and control group

  16. paCO2 [ Time Frame: at hours 0,6,12,24,48,72 post establishment of extracorporal membrane oxygenation (ECMO) ]
    The arterial partial pressure of carbon dioxide as measured by point-of-care blood gas analysis is going to be compared between intervention and control group.

  17. SaO2 [ Time Frame: at hours 0,6,12,24,48,72 post establishment of extracorporal membrane oxygenation (ECMO) ]
    The saturation of hemoglobine with oxygen in an arterial blood sample as measured by point-of-care blood gas analysis is going to be compared between intervention and control group.

  18. SvO2 [ Time Frame: at hours 0,6,12,24,48,72 post establishment of extracorporal membrane oxygenation (ECMO) ]
    The saturation of hemoglobine with oxygen in a central venous blood sample as measured by point-of-care blood gas analysis is going to be compared between intervention and control group.

  19. Horowitz index [ Time Frame: at hours 0,6,12,24,48,72 post establishment of extracorporal membrane oxygenation (ECMO) ]
    The Horowitz index, calculated as paO2/FiO2 is going to be compared between intervention and control group.

  20. pH [ Time Frame: at hours 0,6,12,24,48,72 post establishment of extracorporal membrane oxygenation (ECMO) ]
    The pH of an arterial blood sample is going to be compared between intervention and control group.

  21. HCO3 [ Time Frame: at hours 0,6,12,24,48,72 post establishment of extracorporal membrane oxygenation (ECMO) ]
    The levels of bicarbonate of an arterial blood sample are going to be compared between intervention and control group.

  22. BE [ Time Frame: at hours 0,6,12,24,48,72 post establishment of extracorporal membrane oxygenation (ECMO) ]
    The base excess of an arterial blood sample is going to be compared between intervention and control group.

  23. N [ Time Frame: at hours 0,6,12,24,48,72 post establishment of extracorporal membrane oxygenation (ECMO) ]
    The blood levels of sodium are going to be compared between intervention and control group.

  24. K [ Time Frame: at hours 0,6,12,24,48,72 post establishment of extracorporal membrane oxygenation (ECMO) ]
    The blood levels of potassium are going to be compared between intervention and control group.

  25. C [ Time Frame: at hours 0,6,12,24,48,72 post establishment of extracorporal membrane oxygenation (ECMO) ]
    The blood levels of chloride are going to be compared between intervention and control group.

  26. Lactate [ Time Frame: at hours 0,6,12,24,48,72 post establishment of extracorporal membrane oxygenation (ECMO) ]
    The blood levels of lactate are going to be compared between intervention and control group.

  27. Mode of Ventilation [ Time Frame: at hours 0,6,12,24,48,72 post establishment of extracorporal membrane oxygenation (ECMO) ]
    The mode of mechanical ventilation is going to be compared between intervention and control group

  28. FiO2 [ Time Frame: at hours 0,6,12,24,48,72 post establishment of extracorporal membrane oxygenation (ECMO) ]
    The inspiratory oxygen fraction at mechanical ventilation is going to be compared between intervention and control group

  29. Peak inspiratory pressure (pmax) [ Time Frame: at hours 0,6,12,24,48,72 post establishment of extracorporal membrane oxygenation (ECMO) ]
    The peak inspiratory pressure at mechanical ventilation is going to be compared between intervention and control group

  30. PEEP [ Time Frame: at hours 0,6,12,24,48,72 post establishment of extracorporal membrane oxygenation (ECMO) ]
    The positive end exspiratory pressure at mechanical ventilation is going to be compared between intervention and control group

  31. Ventilation frequency [ Time Frame: at hours 0,6,12,24,48,72 post establishment of extracorporal membrane oxygenation (ECMO) ]
    The frequency of mechanical ventilation (cycles/min) is going to be compared between intervention and control group.

  32. Tidal volume [ Time Frame: at hours 0,6,12,24,48,72 post establishment of extracorporal membrane oxygenation (ECMO) ]
    The tidal volume achieved by mechanical ventilation is going to be compared between intervention and control group.

  33. Total minute ventilation [ Time Frame: at hours 0,6,12,24,48,72 post establishment of extracorporal membrane oxygenation (ECMO) ]
    The total minute ventilation as measured by the ventilation unit is going to be compared between intervention and control group.

  34. Complicance [ Time Frame: at hours 0,6,12,24,48,72 post establishment of extracorporal membrane oxygenation (ECMO) ]
    The airway compliance (c) as calculated from ventilator driving pressure(dp=pmax-PEEP) and tidal volume (V): c=V/dp is going to be compared between intervention and control group.

  35. ASAT [ Time Frame: at hours 0,6,12,24,48,72 post establishment of extracorporal membrane oxygenation (ECMO) ]
    The plasma levels of asparic acid aminotransferase will be compared between intervention and treatment group.

  36. ALAT [ Time Frame: at hours 0,6,12,24,48,72 post establishment of extracorporal membrane oxygenation (ECMO) ]
    The plasma levels of alanin aminotransferase will be compared between intervention and treatment group.

  37. INR [ Time Frame: at hours 0,6,12,24,48,72 post establishment of extracorporal membrane oxygenation (ECMO) ]
    The thrombin time as standardized international normal ratio will be compared between intervention and treatment group.

  38. apTT [ Time Frame: at hours 0,6,12,24,48,72 post establishment of extracorporal membrane oxygenation (ECMO) ]
    The activated partial thromboplastin time will be compared between intervention and treatment group.

  39. Crea [ Time Frame: at hours 0,6,12,24,48,72 post establishment of extracorporal membrane oxygenation (ECMO) ]
    The plasma creatinine concentration will be compared between intervention and treatment group.

  40. eGFR [ Time Frame: at hours 0,6,12,24,48,72 post establishment of extracorporal membrane oxygenation (ECMO) ]
    The glomerulary filtration rate, estimated from serum creatinine by the CKP-EPI formula will be compared between intervention and treatment group.

  41. Volume status [ Time Frame: at hours 0,6,12,24,48,72 post establishment of extracorporal membrane oxygenation (ECMO) ]
    For a clinical estimation of the renal function, the following parameters are extracted from the digital PDMS: Fluid intake, diuresis, additional loss of body fluids (e.g. gastral reflux, vomitting, extraction by kidney replacement therapy)

  42. NSE [ Time Frame: at hours 0,6,12,24,48,72 post establishment of extracorporal membrane oxygenation (ECMO) ]
    The serum levels of neuron specific enolase will be compared between intervention and treatment group.

  43. Mortality [ Time Frame: 30 days post enrollment ]
    Mortality within 30 days after enrollment due to any cause will be determined, if follow up is technically feasible



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03632837


Contacts
Layout table for location contacts
Contact: Jens Kubitz, Prof. Dr. +49 (0) 40 7410 - 52415 j.kubitz@uke.de
Contact: Eike Pfefferkorn, Dr. e.pfefferkorn@uke.de

Locations
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Germany
University Hospital Hamburg-Eppendorf Recruiting
Hamburg, Germany, 20246
Contact: Jens Kubitz, Prof. Dr.    +49 (0) 40 7410 - 52415    j.kubitz@uke.de   
Contact: Eike Pfefferkorn, Dr.       e.pfefferkorn@uke.de   
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
CytoSorbents Corporation and CytoSorbents Medical Inc.
Investigators
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Principal Investigator: Jens Kubitz, Prof. Dr. Universitätsklinikum Hamburg-Eppendorf
  Study Documents (Full-Text)

Documents provided by Universitätsklinikum Hamburg-Eppendorf:
Study Protocol  [PDF] December 29, 2017


Publications:

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Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT03632837     History of Changes
Other Study ID Numbers: UKEHANRAE
First Posted: August 16, 2018    Key Record Dates
Last Update Posted: August 16, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
extracorporal circulation
hemoadsorption
post resuscitation syndrome

Additional relevant MeSH terms:
Layout table for MeSH terms
Inflammation
Heart Arrest
Pathologic Processes
Heart Diseases
Cardiovascular Diseases