Role of Cytosorb in Left Ventricular Assist Device Implantation
- Conditions
- Heart Failure
- Interventions
- Device: CytoSorb 300 mL device
- Registration Number
- NCT04596813
- Lead Sponsor
- Imperial College London
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
Adult patients (≥18 years), but ≤70 years; Scheduled for elective LVAD implantation with the use of cardiopulmonary bypass; Written informed consent for participation
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description standard of care and treatment with the Cytosorb® device CytoSorb 300 mL device -
- Primary Outcome Measures
Name Time Method Increase in plasma IL-6 concentration from baseline to the time of arrival to intensive care unit (approximately 4 hours).
- Secondary Outcome Measures
Name Time Method Time of mechanical ventilation From Baseline through ICU discharge (approximately 7 days) Duration of invasive mechanical ventilation
28 day mortality 28 days after surgery Changes in IL-6 concentrations at various time points after surgery until ICU discharge from baseline, 6, 12, 24, 48 and 72 hours after surgery and at ICU discharge, approximately 7 days Length of ICU stay From Baseline through ICU discharge (approximately 7 days) Incidence of serious device related adverse events from the time of enrolment through ICU discharge from the time of enrolment through ICU discharge (approximately 7 days) Feasibility based on number of patients eligible and receiving study intervention From Baseline through ICU discharge (approximately 7 days) Ratio of eligible patients and those receiving study intervention
Incidence and progression of vasoplegia from baseline to 24 hours after surgery Defined as haemodynamic instability fulfilling the following criteria for at least three consecutive hours during the first 48h after ICU arrival: MAP ≤50 mmHg or SVR ≤800 dynes·s·cm- 5; CI ≥ 2.5 l·min- 1·m- 2; use of norepinephrine ≥200 ng·kg- 1·min- 1 or equivalent doses of vasopressors (epinephrine ≥200 ng·kg- 1·min- 1; dopamine ≥30 μg·kg- 1·min- 1; phenylephrine ≥2 μg·kg- 1·min- 1, or vasopressin ≥0.08 U·min- 1)
Prevalence of right ventricle dysfunction From baseline to 72 hours after surgery Transesophageal echocardiography indices of right ventricle dysfunction based on TAPSE, estimates of the RV-PA coupling, 3D volumetry and ventricle free wall strain
Incidence and progression of Acute Kidney Injury (KDIGO criteria) From Baseline through ICU discharge (approximately 7 days) Prevalence of liver dysfunction from baseline to 72 hours after surgery 14. Defined as changes in indocyanine green plasma disappearance rate masured by the LiMON® monitor
Sequential Organ Failure Assessment Score (SOFA) From Baseline through ICU discharge (approximately 7 days) Total Daily SOFA Score. The score ranges from 0 (best outcome) to 24 (worst outcome).
Trial Locations
- Locations (1)
Harefield Hospital
🇬🇧Harefield, United Kingdom