Role of Cytosorb in Left Ventricular Assist Device Implantation

NCT04596813 | Recruiting DMC

• 1 other identifier: 18IC4535
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

cardiac surgery; inflammation; cytokines; bypass; artificial heart known as LVAD

Outcome Measures

Primary Outcomes (1)

• Increase in plasma IL-6 concentration

  from baseline to the time of arrival to intensive care unit (approximately 4 hours).

Secondary Outcomes (11)

• 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

• 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)

• Incidence and progression of vasoplegia

  from baseline to 24 hours after surgery

• Prevalence of right ventricle dysfunction

  From baseline to 72 hours after surgery

Other Outcomes (2)

• Changes in inflammasome analyses

  from baseline, 6, 12, 24, 48 and 72 hours after surgery and at ICU discharge, approximately 7 days

• Changes in the metabolomics profile

  from baseline, 6, 12, 24, 48 and 72 hours after surgery and at ICU discharge, approximately 7 days

Study Arms (2)

standard of care

NO INTERVENTION

standard of care and treatment with the Cytosorb® device

ACTIVE COMPARATOR

Device: CytoSorb 300 mL device

Interventions

CytoSorb 300 mL device DEVICE

Intra-and postoperative CytoSorb hemoadsorption

standard of care and treatment with the Cytosorb® device

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College London: lead
• UMC Utrecht: collaborator
• CytoSorbents, Inc: collaborator

Study Sites (1)

Harefield Hospital

Harefield, United Kingdom

RECRUITING

MeSH Terms

Conditions

Heart Failure; Inflammation

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nandor Marczin, MD PhD

  Imperial College London

  STUDY CHAIR

• Eric EC de Waal

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nandor Marczin

CONTACT

+44 1895 823 737; n.marczin@imperial.ac.uk

Eric EC de Waal

CONTACT

+88 75 563 76; e.e.c.dewaal@umcutrecht.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2020
• First Posted: October 22, 2020
• Study Start: September 21, 2020
• Primary Completion: December 31, 2024
• Study Completion: June 30, 2025
• Last Updated: April 18, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)