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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04596813
Recruitment Status : Recruiting
First Posted : October 22, 2020
Last Update Posted : October 22, 2020
Sponsor:
Collaborators:
UMC Utrecht
CytoSorbents, Inc
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Heart Failure Device: CytoSorb 300 mL device Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: CYtosorb Modulation of surgiCal infLammatiON During LVAD insErtion
Estimated Study Start Date : October 15, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
No Intervention: standard of care
Active Comparator: standard of care and treatment with the Cytosorb® device Device: CytoSorb 300 mL device
Intra-and postoperative CytoSorb hemoadsorption




Primary Outcome Measures :
  1. Increase in plasma IL-6 concentration [ Time Frame: from baseline to the time of arrival to intensive care unit (approximately 4 hours). ]

Secondary Outcome Measures :
  1. Changes in IL-6 concentrations at various time points after surgery until ICU discharge [ Time Frame: from baseline, 6, 12, 24, 48 and 72 hours after surgery and at ICU discharge, approximately 7 days ]
  2. Incidence of serious device related adverse events from the time of enrolment through ICU discharge [ Time Frame: from the time of enrolment through ICU discharge (approximately 7 days) ]
  3. Feasibility based on number of patients eligible and receiving study intervention [ Time Frame: From Baseline through ICU discharge (approximately 7 days) ]
    Ratio of eligible patients and those receiving study intervention

  4. Incidence and progression of vasoplegia [ Time Frame: 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)

  5. Prevalence of right ventricle dysfunction [ Time Frame: 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

  6. Incidence and progression of Acute Kidney Injury (KDIGO criteria) [ Time Frame: From Baseline through ICU discharge (approximately 7 days) ]
  7. Prevalence of liver dysfunction [ Time Frame: from baseline to 72 hours after surgery ]
    14. Defined as changes in indocyanine green plasma disappearance rate masured by the LiMON® monitor

  8. Sequential Organ Failure Assessment Score (SOFA) [ Time Frame: From Baseline through ICU discharge (approximately 7 days) ]
    Total Daily SOFA Score. The score ranges from 0 (best outcome) to 24 (worst outcome).

  9. Time of mechanical ventilation [ Time Frame: From Baseline through ICU discharge (approximately 7 days) ]
    Duration of invasive mechanical ventilation

  10. Length of ICU stay [ Time Frame: From Baseline through ICU discharge (approximately 7 days) ]
  11. 28 day mortality [ Time Frame: 28 days after surgery ]

Other Outcome Measures:
  1. Changes in inflammasome analyses [ Time Frame: from baseline, 6, 12, 24, 48 and 72 hours after surgery and at ICU discharge, approximately 7 days ]
    Plasma and urinary levels of the inflammatory mediators: IL-1β,IL-1Ra, IL-6, IL-8, IL-10, TNF-α, MPO and HBP [pg/ml for all]

  2. Changes in the metabolomics profile [ Time Frame: from baseline, 6, 12, 24, 48 and 72 hours after surgery and at ICU discharge, approximately 7 days ]
    Changes in the metabolomics profile (fold changes) measured by LC-MS and NMR platforms



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04596813


Contacts
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Contact: Nandor Marczin +44 1895 823 737 n.marczin@imperial.ac.uk
Contact: Eric EC de Waal +88 75 563 76 e.e.c.dewaal@umcutrecht.nl

Locations
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United Kingdom
Harefield Hospital Recruiting
Harefield, United Kingdom
Contact: Nandor Marczin    4401895823737      
Contact: Louise Moss    4401895823737      
Sponsors and Collaborators
Imperial College London
UMC Utrecht
CytoSorbents, Inc
Investigators
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Study Chair: Nandor Marczin, MD PhD Imperial College London
Principal Investigator: Eric EC de Waal UMC Utrecht
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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT04596813    
Other Study ID Numbers: 18IC4535
First Posted: October 22, 2020    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Imperial College London:
cardiac surgery
inflammation
cytokines
bypass
artificial heart known as LVAD
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases