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

NCT05027529 | Completed

• 2 other identifiers: ZKSJ0131DRKS00025265
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Cardiogenic Shock

Keywords

cardiogenic shock; VA-ECMO; venous arterial Extracorporeal Membrane Oxygenation; inotropic score; extracorporeal cytokine hemadsorption system; cytokine adsorber; intensive care; multi organ failure

Outcome Measures

Primary Outcomes (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 \[μg/kg/min\]

  72 hours

Secondary Outcomes (38)

• Interleukin 6

  0 to 7 days after beginning of intervention

• Procalcitonin

  0 to 7 days after beginning of intervention

• c-reactive protein

  0 to 7 days after beginning of intervention

• lactate

  0 to 7 days after beginning of intervention

• creatinine

  0 to 7 days after beginning of intervention

Study Arms (2)

VA-ECMO and CytoSorb

EXPERIMENTAL

standard ICU care WITH CytoSorb

Device: CytoSorb

VA-ECMO only

PLACEBO COMPARATOR

standard ICU care WITHOUT CytoSorb

Other: VA-ECMO only

Interventions

CytoSorb DEVICE

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

Also known as: Standard ICU care (with VA-ECMO) AND CytoSorb Adsorber

VA-ECMO and CytoSorb

VA-ECMO only OTHER

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

Also known as: Standard ICU care (with VA-ECMO)

VA-ECMO only

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Christian Schulze: lead

Study Sites (1)

Jena University Hospital, Department of Cardiology

Jena, Thuringia, 07747, Germany

Location

MeSH Terms

Conditions

Shock, Cardiogenic; Multiple Organ Failure

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Study Officials

• Christian Schulze, Prof.

  Jena University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: masking by using a "black-box"; the control group only receives a regular ECMO tube
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. med.

Model Details: prospective, randomized, controlled, blinded, monocenter trial

Study Record Dates

• First Submitted: March 12, 2021
• First Posted: August 30, 2021
• Study Start: May 21, 2021
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 4, 2026

Record last verified: 2026-02

Locations

DE (1)