CytoSorb REduction of FREe Hemoglobin/Acute Kidney Injury (AKI) during Cardiac Surgery (REFRESH II Trial) Grant uri icon

abstract

  • CytoSorb REduction of FREe Hemoglobin/Acute Kidney Injury (AKI) during Cardiac Surgery (REFRESH II Trial) Prospective, multi-center, randomized, pivotal double-blinded clinical study. Subjects will be randomized in a 1:1 ratio to either standard of care (SOC) alone or standard of care plus treatment with the CytoSorb device, with or without HCA. No more than 33% of all study enrollment will be cardiac surgery cases with HCA. CytoSorb is a sorbent-filled hemoperfusion cartridge that is designed to reduce plasma free hemoglobin (pfHb) and other inflammatory mediators from blood that are generated during cardiopulmonary bypass in cardiac surgery. The device is placed into a parallel bypass circuit (between the oxygenator and the venous reservoir) to the main blood flow in a standard heart-lung machine. The first device will be introduced at t=0 (start of CPB). The second device will be introduced at t=90 minutes after the start of CPB. Up to 400 subjects will be enrolled and randomized at a 1:1 ratio at up to 40 investigational sites in the United States. The primary effectiveness endpoint is the incidence or severity of AKI in the first 48 hours after surgery when used intraoperatively with cardiopulmonary bypass (CPB) in subjects undergoing cardiac surgery as defined by the KDIGO clinical practice guideline through 48 hours post cardiac surgery. Assessment of serum creatinine and hourly measurements of urine output will be operationalized by standard of care measurements on successive post-operative days (1 and 2)

date/time interval

  • August 2019 - May 2022