Ignite Creation Date:
2024-05-06 @ 3:19 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04596813
Status:
RECRUITING
Last Update Posted:
2024-04-18
First Post:
2020-09-23
Brief Title:
Role of Cytosorb in Left Ventricular Assist Device Implantation
Sponsor:
Imperial College London
Organization:
Imperial College London
Study Overview
Official Title:
CYtosorb Modulation of surgiCal infLammatiON During LVAD insErtion
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CYCLONE-LVAD
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
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
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 patients 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
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 patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None