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Cardiogenic ShockECMOsorbNCT05027529

ECMOsorb Trial - Impact of a VA-ECMO in Combination With CytoSorb in Critically Ill Patients With Cardiogenic Shock

A study testing CytoSorb and VA-ECMO only in people with Cardiogenic Shock, run by Christian Schulze at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In the ECMOsorb study the impact of a veno-arterial -ECMO in combination with an extracorporeal cytokine hemadsorption system in critically ill patients with cardiogenic shock is to be examined Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Cardiogenic Shock
What is being tested?
CytoSorb and VA-ECMO only
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
42 participants
Where
1 siteGermany
Study dates
21 May 2021to 31 Dec 2025
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Cardiogenic shock of any cause and indication for VA-ECMO
  • Age between 18 and 80
  • Signed informed consent

Who cannot join

  • Current participation in another interventional trial
  • Pregnancy
  • Current immunosuppressive or immunomodulatory therapy
  • Contraindications to VA-ECMO implantation.
  • Patients with pre - existing sepsis (raised CPR, positive PCT, leukozytosis, fever, positive blood cultures).
  • Shock duration> 12 h before evaluation.
Show all 16Show fewer
  • Severe PVD (peripheral vessel disease) making ECMO-implantation impossible.
  • Aortic valve insufficiency / stenosis at least II °.
  • Age > 80 years.
  • CNS disease with fixed, dilated pupils (not drug-induced).
  • Severe concomitant disease with limited life expectancy <6 months.
  • CPR> 60min.
  • Shock due to other reasons
  • HIT positive (Heparin induced thrombocytopenia)
  • Very low platelet counts (< 20,000/µl)
  • Body weight less than 45 kg

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Jena University Hospital, Department of Cardiology

    Jena, Thuringia, 07747

Other trials in Germany

About this study

Official title: ECMOsorb Trial - Impact of a VA-ECMO in Combination With CytoSorb in Critically Ill Patients With Cardiogenic Shock- A Prospective, Randomized, Blinded, Monocenter Trial.

In the ECMOsorb study the impact of a veno-arterial -ECMO in combination with an extracorporeal cytokine hemadsorption system in critically ill patients with cardiogenic shock is to be examined

Read the detailed description

The prospective, interventional, randomised controlled and blinded ECMOsorb study investigates in critically ill patinets with cardiogenic shock and with veno-arterial ECMO (VA-ECMO) treatment the impact of an extracorporeal cytokin hemadsorption system on hemodynamics, defined by the Inotropic Score 72 hours after initiation of the adsorber (intervention) or normal ECMO tube (control) in the VA-ECMO.

Being tested
CytoSorb, VA-ECMO only
Keywords
cardiogenic shock, VA-ECMO, venous arterial Extracorporeal Membrane Oxygenation, inotropic score, extracorporeal cytokine hemadsorption system, cytokine adsorber, intensive care, multi organ failure
Medical subject headings
Shock, Cardiogenic, Multiple Organ Failure

What participants receive

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

  • CytoSorbDevice

    Also called Standard ICU care (with VA-ECMO) AND CytoSorb Adsorber

    An extracorporeal cytokine hemoadsorption system is integrated in the VA-ECMO circuit

  • VA-ECMO onlyOther

    Also called Standard ICU care (with VA-ECMO)

    only VA-ECMO; NO extracorporeal cytokine hemoadsorption system is added

Study groups in NCT05027529
Study groupRoleWhat they receive
VA-ECMO and CytoSorbExperimentalstandard ICU care WITH CytoSorb
Receives: Device: CytoSorb
VA-ECMO onlyPlacebo comparatorstandard ICU care WITHOUT CytoSorb
Receives: Other: VA-ECMO only

What is being measured

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

  1. Change in inotropic score after 72h (difference between the two study groups)

    Inotropic Score: dopamine dose [μg/kg/min] + dobutamine dose [μg/kg/min] + 100x epinephrine dose [μg/kg/min] + 100x norepinephrine [μg/kg/min]

    Measured: 72 hours

Secondary outcomes (38)

  1. Interleukin 6

    pg/ml

    Measured: 0 to 7 days after beginning of intervention

  2. Procalcitonin

    ng/ml

    Measured: 0 to 7 days after beginning of intervention

  3. c-reactive protein

    mg/l

    Measured: 0 to 7 days after beginning of intervention

  4. lactate

    mmol/l

    Measured: 0 to 7 days after beginning of intervention

  5. creatinine

    µmol/l

    Measured: 0 to 7 days after beginning of intervention

  6. glomerular filtration rate (GFR)

    ml/min

    Measured: 0 to 7 days after beginning of intervention

  7. troponin

    pg/ml

    Measured: 0 to 7 days after beginning of intervention

  8. creatinine kinase

    µmol/l*s

    Measured: 0 to 7 days after beginning of intervention

  9. myoglobine

    µg/l

    Measured: 0 to 7 days after beginning of intervention

  10. urinary output

    ml/h

    Measured: 0 to 7 days after beginning of intervention

  11. neuron specific enolase

    µg/l

    Measured: 0 to 7 days after beginning of intervention

  12. s-100

    µg/l

    Measured: 0 to 7 days after beginning of intervention

  13. cystatin c

    mg/l

    Measured: 0 to 7 days after beginning of intervention

  14. galectin-3

    ng/ml

    Measured: 0 to 7 days after beginning of intervention

  15. Duration of: renal replacement therapy (CVVHD), mechanical ventilation, ECMO therapy, inotropic /vasopressor treatment

    hours

    Measured: day 30 after beginning of intervention

  16. 30 day, ICU and in-hospital mortality

    nominal scale (yes/no)

    Measured: day 30 after beginning of intervention

  17. Length of stay in ICU and total length of hospital stay until discharge/transfer

    hours

    Measured: day 30 after beginning of intervention

  18. Necessary Implantation of an Active Assist Device or heart transplantation

    nominal scale (yes/no)

    Measured: day 30 after beginning of intervention

  19. SAPS II

    Simplified Acute Physiology Score II (Minimum value: 0 / maximum value: 163; higher values means worse outcome)

    Measured: 0 to 7 days after beginning of intervention

  20. APACHE II score

    Acute Pysiology and Chronic Health Evaluation II (Minimum value: 0 / maximum value: 71; higher values means worse outcome)

    Measured: 0 to 7 days after beginning of intervention

  21. SOFA score

    Sequential Organ Failure Assessment Score (Minimum value: 0 / maximum value: 24; higher value means worse outcome)

    Measured: 0 to 7 days after beginning of intervention

  22. cerebreal performance category (CPC)

    CPC 1 (adequate function) to CPC 5 (brain dead)

    Measured: 0 to 30 days after beginning of intervention

  23. Glasgow coma scale (GCS)

    Assessment scheme for disorders of consciousness and brain function (eyes, verbal, motor); scale from 3 (severe impairment) to 15 points (no abnormalities)

    Measured: 0 to 30 days after beginning of intervention

  24. EuroQuol 5D-3L Descriptive System

    mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems.

    Measured: 7 to 30 days after beginning of intervention

  25. EQ VAS

    EQ visual analogue scale (EQ VAS), patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'.

    Measured: 7 to 30 days after beginning of intervention

  26. Modified Rankin scale

    scale from 0 (no symptoms) to 6 (dead);

    Measured: 0 to 30 days after beginning of intervention

  27. Measurement of right ventricular parameters

    measurements of right ventricular function in the echo (TAPSE in mm; FAC in %; RVEDD in mm; sPAP in mmHg; RA area in cm²; TASV in cm/s; ICV in mm)

    Measured: 0 to 7 days after beginning of intervention

  28. Measurement of left ventricular parameters

    measurements of left ventricular function in the echo (LVEDD in mm; LVESD in mm; LVEF in %; VSD (yes/no); LVEDV in ml; LVESV in ml; GLS in %; LA volume in ml)

    Measured: 0 to 7 days after beginning of intervention

  29. Measurement of kidney injury and kidney function

    NGAL, KIM-1, L-FABP, IGFBP7 in ng/ml

    Measured: 0 to 7 days after beginning of intervention

  30. Interleukin 18

    pg/ml

    Measured: 0 to 7 days after beginning of intervention

  31. incidence of apoplexy

    nominal scale (yes/no)

    Measured: 30 days after beginning of intervention

  32. mean arterial pressure

    mmHg

    Measured: 0 to 7 days after beginning of intervention

  33. central venous oxygen saturation

    in %

    Measured: 0 to 7 days after beginning of intervention

  34. mixed venous oxygen saturation

    in %

    Measured: 0 to 7 days after beginning of intervention

  35. arterial oxygen saturation

    in %

    Measured: 0 to 7 days after beginning of intervention

  36. heart failure re-hospitalisation

    nominal scale (yes/no)

    Measured: 30 days after beginning of intervention

  37. Brain natriuretic peptide (BNP)

    pg/ml

    Measured: 0 to 7 days after beginning of intervention

  38. n-terminal pro brain natriuretic peptide (NT-proBNP)

    pg/ml

    Measured: 0 to 7 days after beginning of intervention

Timeline

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

  1. First posted30 Aug 2021
  2. Study start21 May 2021
  3. Primary completion31 Dec 2025
  4. Study completion31 Dec 2025

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
Model description
prospective, randomized, controlled, blinded, monocenter trial
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05027529
Sponsor's protocol ID
ZKSJ0131
Other IDs
DRKS00025265
Acronym
ECMOsorb
Status last verified
Feb 2026
First submitted
12 Mar 2021
Last updated
4 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing CytoSorb and VA-ECMO only in people with Cardiogenic Shock, run by Christian Schulze 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 3 inclusion and 16 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: finished, as of the sponsor's last update on 4 Feb 2026. 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. Some participants in this study may receive a placebo. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in inotropic score after 72h (difference between the two study groups) (time frame: 72 hours). 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 NCT05027529.

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 4 Feb 2026.

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