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Completed

NCT Number: NCT05027529

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

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

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Key information

Conditions

Cardiogenic Shock Cardiovascular Diseases Heart Diseases Infarction Ischemia Multiple Organ Failure Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Shock Shock, Cardiogenic Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jena University Hospital, Department of Cardiology

Jena, Thuringia, 07747, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.
  • 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

Treatment and study plan

CytoSorb

Device

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

Other names: Standard ICU care (with VA-ECMO) AND CytoSorb Adsorber

VA-ECMO only

Other

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

Other names: Standard ICU care (with VA-ECMO)

Primary outcomes

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

    Time frame: 72 hours

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

Secondary outcomes

  1. Interleukin 6

    Time frame: 0 to 7 days after beginning of intervention

    pg/ml

  2. Procalcitonin

    Time frame: 0 to 7 days after beginning of intervention

    ng/ml

  3. c-reactive protein

    Time frame: 0 to 7 days after beginning of intervention

    mg/l

  4. lactate

    Time frame: 0 to 7 days after beginning of intervention

    mmol/l

  5. creatinine

    Time frame: 0 to 7 days after beginning of intervention

    µmol/l

  6. glomerular filtration rate (GFR)

    Time frame: 0 to 7 days after beginning of intervention

    ml/min

  7. troponin

    Time frame: 0 to 7 days after beginning of intervention

    pg/ml

  8. creatinine kinase

    Time frame: 0 to 7 days after beginning of intervention

    µmol/l*s

  9. myoglobine

    Time frame: 0 to 7 days after beginning of intervention

    µg/l

  10. urinary output

    Time frame: 0 to 7 days after beginning of intervention

    ml/h

  11. neuron specific enolase

    Time frame: 0 to 7 days after beginning of intervention

    µg/l

  12. s-100

    Time frame: 0 to 7 days after beginning of intervention

    µg/l

  13. cystatin c

    Time frame: 0 to 7 days after beginning of intervention

    mg/l

  14. galectin-3

    Time frame: 0 to 7 days after beginning of intervention

    ng/ml

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

    Time frame: day 30 after beginning of intervention

    hours

  16. 30 day, ICU and in-hospital mortality

    Time frame: day 30 after beginning of intervention

    nominal scale (yes/no)

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

    Time frame: day 30 after beginning of intervention

    hours

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

    Time frame: day 30 after beginning of intervention

    nominal scale (yes/no)

  19. SAPS II

    Time frame: 0 to 7 days after beginning of intervention

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

  20. APACHE II score

    Time frame: 0 to 7 days after beginning of intervention

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

  21. SOFA score

    Time frame: 0 to 7 days after beginning of intervention

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

  22. cerebreal performance category (CPC)

    Time frame: 0 to 30 days after beginning of intervention

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

  23. Glasgow coma scale (GCS)

    Time frame: 0 to 30 days after beginning of intervention

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

  24. EuroQuol 5D-3L Descriptive System

    Time frame: 7 to 30 days after beginning of intervention

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

  25. EQ VAS

    Time frame: 7 to 30 days after beginning of intervention

    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'.

  26. Modified Rankin scale

    Time frame: 0 to 30 days after beginning of intervention

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

  27. Measurement of right ventricular parameters

    Time frame: 0 to 7 days after beginning of intervention

    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)

  28. Measurement of left ventricular parameters

    Time frame: 0 to 7 days after beginning of intervention

    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)

  29. Measurement of kidney injury and kidney function

    Time frame: 0 to 7 days after beginning of intervention

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

  30. Interleukin 18

    Time frame: 0 to 7 days after beginning of intervention

    pg/ml

  31. incidence of apoplexy

    Time frame: 30 days after beginning of intervention

    nominal scale (yes/no)

  32. mean arterial pressure

    Time frame: 0 to 7 days after beginning of intervention

    mmHg

  33. central venous oxygen saturation

    Time frame: 0 to 7 days after beginning of intervention

    in %

  34. mixed venous oxygen saturation

    Time frame: 0 to 7 days after beginning of intervention

    in %

  35. arterial oxygen saturation

    Time frame: 0 to 7 days after beginning of intervention

    in %

  36. heart failure re-hospitalisation

    Time frame: 30 days after beginning of intervention

    nominal scale (yes/no)

  37. Brain natriuretic peptide (BNP)

    Time frame: 0 to 7 days after beginning of intervention

    pg/ml

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

    Time frame: 0 to 7 days after beginning of intervention

    pg/ml

Sponsors and collaborators

Lead sponsor

Christian Schulze

Other

Registry information

Official study 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.

Acronym: ECMOsorb

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Aug 30, 2021
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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