Role of Cytosorb in Left Ventricular Assist Device Implantation

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    60
  • sponsor
    Imperial College London
Updated on 26 January 2021
heart failure
heart transplantation

Summary

Mechanical circulatory support, specifically implantable continuous flow left ventricular assist device (CF-LVAD) therapy has been established as a viable treatment for rapidly deteriorating patients suffering from end stage heart failure either as bridge or alternative to heart transplantation. However, a large proportion of these patients experience severe complications in the early postoperative period including right ventricular failure or multi organ failure leading to increased mortality. The leading theory explaining these complications involves exaggerated systemic inflammatory response prior to, during and early after CF-LVAD insertion. Among the cytokines IL-6 appears to play a major role. There is increasing demonstration of the efficacy of a cytokine haemoadsorption (HA) technology in attenuating cytokine response and particularly IL-6 in various inflammatory states and emerging data on the safety of the Cytosorb device in routine and complex cardiac surgery.

The study team hypothesizes that Cytosorb treatment is feasible and safe in heart failure patients undergoing LVAD insertion and that it is effective in attenuating IL-6 secretion with benefit in the wider inflammatory and metabolic response to this high-risk surgery.

Description

The principle objectives of this study are:

  1. To investigate the efficacy of Cytosorb treatment in attenuating perioperative changes in IL-6 during CF-LVAD implantation
  2. To investigate the feasibility, and safety of Cytosorb treatment during CF-LVAD implantation.
  3. To pilot the effect of Cytosorb treatment on vasoplegia and organ dysfunction with specific focus on right ventricle failure, liver failure and acute kidney injury (AKI).
  4. To establish a collaborative biobank of patient's biological samples to allow extensive characterisation of patient phenotype prior to CF-LVAD implantation and their individual inflammatory and metabolic responses to surgery and perioperative management.

Details
Condition Heart failure, Congestive Heart Failure, Heart failure, Heart disease, Heart disease, Cardiac Disease, Congestive Heart Failure, Cardiac Disease, cardiac failure, congestive heart disease
Treatment CytoSorb 300 mL device
Clinical Study IdentifierNCT04596813
SponsorImperial College London
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Adult patients (18 years), but 70 years; Scheduled for elective LVAD
implantation with the use of cardiopulmonary bypass; Written informed consent
for participation

Exclusion Criteria

Poor spoken and/or written language comprehension
Declined or missing informed consent
LVAD implant planned without use of CPB
Total Artificial Heart implantation
Planned CPB temperature < 32 C
AIDS with a CD4 count of < 200/L
Severe thrombocytopenia (PLT <50000
Application of contrast medium on the day of surgery
Immunosuppressive therapy or long-term therapy with corticosteroids
Contraindication to anticoagulation with heparin
Participation in another clinical intervention trial
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