CytoSorb® Reduction of FREee Hemoglobin/Acute Kidney Injury (AKI) During Cardiac Surgery (REFRESH II-AKI)
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ClinicalTrials.gov Identifier: NCT03384875 |
Recruitment Status :
Recruiting
First Posted : December 28, 2017
Last Update Posted : December 2, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Elective Cardiac Surgery | Device: CytoSorb | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 400 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | CytoSorb® Reduction of FREee Hemoglobin/Acute Kidney Injury (AKI) During Cardiac Surgery (REFRESH II Trial) |
Actual Study Start Date : | April 19, 2018 |
Estimated Primary Completion Date : | December 2021 |
Estimated Study Completion Date : | April 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: CytoSorb Device
Standard of care plus treatment with CytoSorb device installed on the Cardiopulmonary bypass (CPB) machine
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Device: CytoSorb
To evaluate the safety and performance of the CytoSorb® device to decrease the incidence or severity of acute kidney injury (AKI)
Other Name: CytoSorb device used during cardiopulmonary bypass (CPB) |
Placebo Comparator: Control
Standard of care
|
Device: CytoSorb
To evaluate the safety and performance of the CytoSorb® device to decrease the incidence or severity of acute kidney injury (AKI)
Other Name: CytoSorb device used during cardiopulmonary bypass (CPB) |
- Incidence or severity of acute kidney injury (AKI) in the first 48 hours after cardiopulmonary pulmonary bypass (CPB) [ Time Frame: From start of CPB through 48 hours after CPB ]Kidney Disease Improving Global Outcomes (KDIGO) definitions for AKI
- Change in maximum plasma free hemoglobin and activated complement from start of CPB through post-surgery day 3 [ Time Frame: From start of CPB through post-surgery day 3 ]Blood sample indices of effects from cardiac surgery with CPB
- Severity or duration of AKI in the first 7 days after CPB [ Time Frame: From start of CPB through 7 days post-cardiac surgery ]KDIGO definitions for AKI

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03384875
Contact: Jenni Stokes, RN | jstokes@cytosorbents.com | ||
Contact: Nikki Medlyn | nmedlyn@namsa.com |

Responsible Party: | CytoSorbents, Inc |
ClinicalTrials.gov Identifier: | NCT03384875 |
Other Study ID Numbers: |
2017-001 |
First Posted: | December 28, 2017 Key Record Dates |
Last Update Posted: | December 2, 2020 |
Last Verified: | November 2020 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Device Product Not Approved or Cleared by U.S. FDA: | Yes |
CytoSorb device Plasma free hemoglobin inflammation |
extracorporeal cardiopulmonary bypass cardiopulmonary bypass Acute Kidney Injury |
Acute Kidney Injury Renal Insufficiency Kidney Diseases Urologic Diseases |