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Cardiac ArrestHANRAENCT03632837

HaemoAdsorption Nach Reanimation An ECMO

A study testing Hemoadsorption in people with Cardiac Arrest and Resuscitation, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Cardiac Arrest, Resuscitation, Inflammation
What is being tested?
Hemoadsorption
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteGermany
Study dates
Oct 2018to Sep 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Jens Kubitz, Prof. Dr. contact

+49 (0) 40 7410 - 52415

j.kubitz@uke.de

Eike Pfefferkorn, Dr. contact

e.pfefferkorn@uke.de

Germany1 site, 1 recruiting

  • University Hospital Hamburg-Eppendorf

    Hamburg, 20246

    Jens Kubitz, Prof. Dr., +49 (0) 40 7410 - 52415, j.kubitz@uke.de

    Eike Pfefferkorn, Dr., e.pfefferkorn@uke.de

    Recruiting

Other trials in Germany

About this study

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.

Read the 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).

Being tested
Hemoadsorption
Keywords
extracorporal circulation, hemoadsorption, post resuscitation syndrome
Medical subject headings
Heart Arrest, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HemoadsorptionDevice

    see arm description

Study groups in NCT03632837
Study groupRoleWhat they receive
TreatmentExperimentalInclusion 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
Receives: Device: Hemoadsorption
ControlNo interventionECMO and standard post resuscitation intensive care without any additional module in extracorporal circulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. IL-6 at hour 6

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

    Measured: 6 hours post establishment of extracorporal membrane oxygenation (ECMO)

  2. IL-6 at hour 12

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

    Measured: 12 hours post establishment of extracorporal membrane oxygenation (ECMO)

  3. IL-6 at hour 24

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

    Measured: 24 hours post establishment of extracorporal membrane oxygenation (ECMO)

  4. IL-6 at hour 48

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

    Measured: 48 hours post establishment of extracorporal membrane oxygenation (ECMO)

  5. IL-6 at hour 72

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

    Measured: 72 hours post establishment of extracorporal membrane oxygenation (ECMO)

  6. TNF-a at hour 6

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

    Measured: 6 hours post establishment of extracorporal membrane oxygenation (ECMO)

  7. TNF-a at hour 12

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

    Measured: 12 hours post establishment of extracorporal membrane oxygenation (ECMO)

  8. TNF-a at hour 24

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

    Measured: 24 hours post establishment of extracorporal membrane oxygenation (ECMO)

  9. TNF-a at hour 48

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

    Measured: 48 hours post establishment of extracorporal membrane oxygenation (ECMO)

  10. TNF-a at hour 72

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

    Measured: 72 hours post establishment of extracorporal membrane oxygenation (ECMO)

Secondary outcomes (43)

  1. S1P

    Blood levels of sphingosine-1-phosphate will be compared between intervention and control group.

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

  2. PCT

    The serum levels of procalcitonine will be compared between intervention and control group.

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

  3. CRP

    The plasma levels of C-related peptide will be compared between intervention and control group.

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

  4. Leukocytes

    The number of leukocytes in simple blood count will be compared between intervention and control group.

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

  5. BNP

    The serum levels of n-terminal pro brain natriuretic peptide will be compared between intervention and control group.

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

  6. Mean arterial pressure (MAP)

    The mean arterial pressure as calculated automatically from the invasively measured arterial pressure curve will be compared between intervention and control group.

    Measured: Continuosly from enrollment to 72h post.

  7. Heart rate (HR)

    The continuously monitored heart rate will be compared between intervention and control group.

    Measured: Continuosly from enrollment to 72h post.

  8. Central venous pressure (CVP)

    The continuously and invasively measured mean central venous pressure will be compared between intervention and control group, if available.

    Measured: Continuosly from enrollment to 72h post.

  9. haemodynamically relevant medication

    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)

    Measured: Continuosly from enrollment to 72h post.

  10. Trop

    The serum levels of troponine T will be compared between intervention and control group

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

  11. CK

    The Plasma levels of creatinkinase will be compared between intervention and control group.

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

  12. Myoglobine

    The Serum levels of myoglobine will be compared between intervention and control group.

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

  13. Hemoglobine

    The total blood concentration of hemoglobine will be compared between intervention and control group.

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

  14. Haptoglobine

    The serum levels of haptoglobine will be compared between intervention and control group.

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

  15. paO2

    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

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

  16. paCO2

    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.

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

  17. SaO2

    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.

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

  18. SvO2

    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.

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

  19. Horowitz index

    The Horowitz index, calculated as paO2/FiO2 is going to be compared between intervention and control group.

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

  20. pH

    The pH of an arterial blood sample is going to be compared between intervention and control group.

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

  21. HCO3

    The levels of bicarbonate of an arterial blood sample are going to be compared between intervention and control group.

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

  22. BE

    The base excess of an arterial blood sample is going to be compared between intervention and control group.

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

  23. N

    The blood levels of sodium are going to be compared between intervention and control group.

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

  24. K

    The blood levels of potassium are going to be compared between intervention and control group.

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

  25. C

    The blood levels of chloride are going to be compared between intervention and control group.

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

  26. Lactate

    The blood levels of lactate are going to be compared between intervention and control group.

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

  27. Mode of Ventilation

    The mode of mechanical ventilation is going to be compared between intervention and control group

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

  28. FiO2

    The inspiratory oxygen fraction at mechanical ventilation is going to be compared between intervention and control group

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

  29. Peak inspiratory pressure (pmax)

    The peak inspiratory pressure at mechanical ventilation is going to be compared between intervention and control group

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

  30. PEEP

    The positive end exspiratory pressure at mechanical ventilation is going to be compared between intervention and control group

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

  31. Ventilation frequency

    The frequency of mechanical ventilation (cycles/min) is going to be compared between intervention and control group.

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

  32. Tidal volume

    The tidal volume achieved by mechanical ventilation is going to be compared between intervention and control group.

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

  33. Total minute ventilation

    The total minute ventilation as measured by the ventilation unit is going to be compared between intervention and control group.

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

  34. Complicance

    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.

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

  35. ASAT

    The plasma levels of asparic acid aminotransferase will be compared between intervention and treatment group.

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

  36. ALAT

    The plasma levels of alanin aminotransferase will be compared between intervention and treatment group.

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

  37. INR

    The thrombin time as standardized international normal ratio will be compared between intervention and treatment group.

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

  38. apTT

    The activated partial thromboplastin time will be compared between intervention and treatment group.

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

  39. Crea

    The plasma creatinine concentration will be compared between intervention and treatment group.

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

  40. eGFR

    The glomerulary filtration rate, estimated from serum creatinine by the CKP-EPI formula will be compared between intervention and treatment group.

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

  41. Volume status

    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)

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

  42. NSE

    The serum levels of neuron specific enolase will be compared between intervention and treatment group.

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

  43. Mortality

    Mortality within 30 days after enrollment due to any cause will be determined, if follow up is technically feasible

    Measured: 30 days post enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Aug 2018
  2. Study startOct 2018 (estimated)
  3. Primary completionMay 2019 (estimated)
  4. Study completionSep 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03632837
Sponsor's protocol ID
UKEHANRAE
Acronym
HANRAE
Status last verified
Aug 2018
First submitted
3 May 2018
Last updated
16 Aug 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 15166838

  • 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.

    PubMed 15090965

  • 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.

    PubMed 18434884

  • 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.

    PubMed 27079418

  • 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.

    PubMed 25656010

  • 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.

    PubMed 27059056

Questions about this trial

What is this clinical trial studying?

A study testing Hemoadsorption in people with Cardiac Arrest and Resuscitation, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jens Kubitz, Prof. Dr. (+49 (0) 40 7410 - 52415, j.kubitz@uke.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

IL-6 at hour 6 (time frame: 6 hours post establishment of extracorporal membrane oxygenation (ECMO)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03632837, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2018.

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