CYtosorb modulation of surgiCal infLammatiON during LVAD insErtion (CYCLONE-LVAD) study
Imperial College London
Duration of Study in the UK
1 years, 8 months, 30 days
End stage heart failure is a devastating condition that may require surgery to insert a heart pump called Left Ventricular Assist Device (LVAD) to help with the function of the left side of the heart to maintain blood flow. Despite this, overall circulation may still be compromised due to problems with the right side of the heart or inability to maintain adequate blood pressure due to paralysis of the vessels (vasoplegia). There are likely multiple factors that contribute to these complications and the leading theory suggest involvement of a whole body response to the surgery and the use of the heart lung machine during surgery called inflammation. One of the prominent players of inflammation are called cytokines, and one of their “master regulator” is called Interleukin 6 (IL-6).
Until recently, little could be done to eliminate these potentially harmful substances, but recently a blood purification device has been approved in the European Union to remove these molecules. The device can be connected to the heart and lung machine during the operation or the blood filters after the operation. Previous studies using the Cytosorb filter have shown removal of cytokines including IL-6 in other inflammatory conditions and some improved clinical outcomes.
We hypothesize that Cytosorb® treatment is feasible and safe in heart failure patients undergoing LVAD insertion and that it is effective in reducing IL-6 production with benefit in the wider inflammatory and metabolic response. To test this, we plan to recruit 60 eligible subjects and randomize them in a 1:1 ratio to either standard of care (SOC) alone or standard of care and treatment with the Cytosorb® device. Primary end point of the study will be plasma IL-6 concentration and secondary endpoints include serious device related adverse events, incidence and progression of organ dysfunction after the operation.
North East - Newcastle & North Tyneside 2 Research Ethics Committee
Date of REC Opinion
19 Jul 2019