Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
CytoSorbents, Inc
To evaluate the safety and performance of the CytoSorb® device to decrease the incidence or severity of acute kidney injury (AKI) as defined by Kidney Disease Improving Global Outcomes (KDIGO) clinical practice guideline definition of acute kidney injury when used intraoperatively with cardiopulmonary bypass (CPB) in subjects undergoing cardiac surgery. The objective of using CytoSorb® treatment in this setting is to provide clinically meaningful improvements in renal function by mitigation of intraoperative injury by removal of nephrotoxic agents such as pfHb and complement. Up to 420 subjects will be enrolled and randomized at a 1:1 ratio at up to 40 investigational sites in the United States.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Scheduled for non-emergent cardiac surgery requiring CPB for i) heart valve replacement with any other procedure, without hypothermic circulatory arrest (HCA), or ii) aortic reconstruction with or without another procedure, with HCA
You may not be if
Isolated Coronary Artery Bypass Graft
Pregnant women
Life expectancy of \< 14 days
End stage organ disease
Active infection
Correction of a congenital heart defect
Contraindication to anticoagulation with heparin
Minimally invasive surgery implantation (TAVI) or transcatheter aortic valve replacement (TAVR)
Declined informed consent
Clareo Health | CytoSorb® Reduction of FREee Hemoglobin/Acute Kidney Injury (AKI) During Cardiac Surgery
