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CytoSorb® Reduction of FREee Hemoglobin/Acute Kidney Injury (AKI) During Cardiac Surgery (REFRESH II-AKI)

  • Study HIC#:2000023693
  • Last Updated:07/15/2021

Prospective, multi-center, randomized, blinded, pivotal 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.

  • Age18 years and older
  • GenderBoth
  • Start Date11/18/2020
  • End Date12/31/2021

Trial Purpose and Description

Prospective, multi-center, randomized, blinded, pivotal 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.

Eligibility Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Principal Investigator

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