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| Name | Class |
|---|---|
| UMC Utrecht | OTHER |
| CytoSorbents, Inc | INDUSTRY |
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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.
The principle objectives of this study are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard of care | No Intervention | ||
| standard of care and treatment with the Cytosorb® device | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CytoSorb 300 mL device | Device | Intra-and postoperative CytoSorb hemoadsorption |
|
| Measure | Description | Time Frame |
|---|---|---|
| Increase in plasma IL-6 concentration | from baseline to the time of arrival to intensive care unit (approximately 4 hours). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in inflammasome analyses | 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] | from baseline, 6, 12, 24, 48 and 72 hours after surgery and at ICU discharge, approximately 7 days |
| Changes in the metabolomics profile |
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Nandor Marczin, MD PhD | Imperial College London | Study Chair |
| Eric EC de Waal | UMC Utrecht | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harefield Hospital | Recruiting | Harefield | United Kingdom |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| from the time of enrolment through ICU discharge (approximately 7 days) |
| Feasibility based on number of patients eligible and receiving study intervention | Ratio of eligible patients and those receiving study intervention | From Baseline through ICU discharge (approximately 7 days) |
| Incidence and progression of vasoplegia | 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) | from baseline to 24 hours after surgery |
| Prevalence of right ventricle dysfunction | Transesophageal echocardiography indices of right ventricle dysfunction based on TAPSE, estimates of the RV-PA coupling, 3D volumetry and ventricle free wall strain | From baseline to 72 hours after surgery |
| Incidence and progression of Acute Kidney Injury (KDIGO criteria) | From Baseline through ICU discharge (approximately 7 days) |
| Prevalence of liver dysfunction | 14. Defined as changes in indocyanine green plasma disappearance rate masured by the LiMON® monitor | from baseline to 72 hours after surgery |
| Sequential Organ Failure Assessment Score (SOFA) | Total Daily SOFA Score. The score ranges from 0 (best outcome) to 24 (worst outcome). | From Baseline through ICU discharge (approximately 7 days) |
| Time of mechanical ventilation | Duration of invasive mechanical ventilation | From Baseline through ICU discharge (approximately 7 days) |
| Length of ICU stay | From Baseline through ICU discharge (approximately 7 days) |
| 28 day mortality | 28 days after surgery |
Changes in the metabolomics profile (fold changes) measured by LC-MS and NMR platforms |
| from baseline, 6, 12, 24, 48 and 72 hours after surgery and at ICU discharge, approximately 7 days |