Impact of a VA-ECMO in combination with an extracorporeal cytokine hemadsorption system in critically ill patients with cardiogenic shock.A prospective, randomized, controlled, blinded, monocenter, trial

Not Applicable

Recruiting

• Conditions: R57.0; Cardiogenic shock

• Registration Number: DRKS00025265
• Lead Sponsor: niversitätsklinikum Jena KIM I, Kardiologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-12
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

Critically ill patients with cardiogenic shock with or without reanimation (CPR),
- indication for VA-ECMO,
- age =18 years =80 years.
- signed informed consent

Exclusion Criteria

• Contraindications to VA-ECMO implantation.
• Patients with pre – existing sepsis (raised CRP, positive PCT, leukocytosis, 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 <18, > 80 years.
• CNS disease with fixed, dilated pupils (not drug-induced).
• Severe concomitant disease with limited life expectancy <6 months.
• Participation in another study.
• CPR> 60min.
• Shock due to other reasons.
• Pregnancy.
• HIT positive (Heparin induced thrombocytopenia).
• Very low platelet counts (< 20,000/µL).
• Body weight less than 45 kg
• Current immunosuppressive or immunomodulatory therapy

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Inotropic Score (IS) improvement after 72 hours after integration of the cytokin hemadsorption system or ECMO tube in VA-ECMO (Inotropic Score = <br> dopamine dose [µg/kg/min] + dobutamine dose [µg/kg/min] + 100x <br> epinephrine dose [µg/kg/min] + 100x norepinephrine [µg/kg/min])