Role of Cytosorb in Left Ventricular Assist Device Implantation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-21

Study Completion Date

2025-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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standard of care

Group Type NO_INTERVENTION

No interventions assigned to this group

standard of care and treatment with the Cytosorb® device

Group Type ACTIVE_COMPARATOR

CytoSorb 300 mL device

Intervention Type DEVICE

Intra-and postoperative CytoSorb hemoadsorption

Interventions

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CytoSorb 300 mL device

Intra-and postoperative CytoSorb hemoadsorption

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No