Role of Cytosorb in Left Ventricular Assist Device Implantation (CYCLONE-LVAD)
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|ClinicalTrials.gov Identifier: NCT04596813|
Recruitment Status : Recruiting
First Posted : October 22, 2020
Last Update Posted : October 22, 2020
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|
The principle objectives of this study are:
- To investigate the efficacy of Cytosorb® treatment in attenuating perioperative changes in IL-6 during CF-LVAD implantation
- To investigate the feasibility, and safety of Cytosorb® treatment during CF-LVAD implantation.
- 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).
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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|
|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
- Increase in plasma IL-6 concentration [ Time Frame: from baseline to the time of arrival to intensive care unit (approximately 4 hours). ]
- 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 ]
- 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) ]
- 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
- 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)
- 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
- Incidence and progression of Acute Kidney Injury (KDIGO criteria) [ Time Frame: From Baseline through ICU discharge (approximately 7 days) ]
- 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
- 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).
- Time of mechanical ventilation [ Time Frame: From Baseline through ICU discharge (approximately 7 days) ]Duration of invasive mechanical ventilation
- Length of ICU stay [ Time Frame: From Baseline through ICU discharge (approximately 7 days) ]
- 28 day mortality [ Time Frame: 28 days after surgery ]
- 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]
- 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
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
|Contact: Nandor Marczin||+44 1895 823 email@example.com|
|Contact: Eric EC de Waal||+88 75 563 firstname.lastname@example.org|
|Harefield, United Kingdom|
|Contact: Nandor Marczin 4401895823737|
|Contact: Louise Moss 4401895823737|
|Study Chair:||Nandor Marczin, MD PhD||Imperial College London|
|Principal Investigator:||Eric EC de Waal||UMC Utrecht|