Role of Cytosorb in Left Ventricular Assist Device Implantation (CYCLONE-LVAD)

Imperial College London

Status: Enrolling

Conditions: Heart Failure

Treatments: Device: CytoSorb 300 mL device

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04596813

18IC4535

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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/μL
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

standard of care

No Intervention group

standard of care and treatment with the Cytosorb® device

Active Comparator group

Treatment:

Device: CytoSorb 300 mL device