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

Elective Cardiac Surgery Clinical Trial

— REFRESH II-AKI  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03384875
• Other study ID #: 2017-001
• Status: Terminated
• Phase: N/A
• Start date: April 19, 2018
• Est. completion date: January 18, 2022

Study information

• Verified date: August 2022
• Source: CytoSorbents, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 116
• Est. completion date: January 18, 2022
• Est. primary completion date: January 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Elective Cardiac Surgery

Intervention

Device:
• CytoSorb
To evaluate the safety and performance of the CytoSorb® device to decrease the incidence or severity of acute kidney injury (AKI)

Locations

Country	Name	City	State
United States	University of Maryland	Baltimore	Maryland
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	University of Chicago	Chicago	Illinois
United States	The Christ Hospital Linder Research Center	Cincinnati	Ohio
United States	Ohio State university	Columbus	Ohio
United States	Duke University Medical Center	Durham	North Carolina
United States	East Carolina University	Greenville	North Carolina
United States	Baylor College of Medicine	Houston	Texas
United States	Indiana University Health Methodist Hospital	Indianapolis	Indiana
United States	University of Louisville	Louisville	Kentucky
United States	Baptist Memorial Hospital	Memphis	Tennessee
United States	Vanderbilt University	Nashville	Tennessee
United States	Yale School of Medicine	New Haven	Connecticut
United States	Columbia University Medical Center	New York	New York
United States	Northwell Health: Lennox Hill Hospital	New York	New York
United States	Integris Baptist Medical Center	Oklahoma City	Oklahoma
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Maine Medical Center	Portland	Maine
United States	Valley Hospital	Ridgewood	New Jersey
United States	Iowa Heart Center	West Des Moines	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
CytoSorbents, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence or severity of acute kidney injury (AKI) in the first 48 hours after cardiopulmonary pulmonary bypass (CPB)	Kidney Disease Improving Global Outcomes (KDIGO) definitions for AKI	From start of CPB through 48 hours after CPB
Secondary	Change in maximum plasma free hemoglobin and activated complement from start of CPB through post-surgery day 3	Blood sample indices of effects from cardiac surgery with CPB	From start of CPB through post-surgery day 3
Secondary	Severity or duration of AKI in the first 7 days after CPB	KDIGO definitions for AKI	From start of CPB through 7 days post-cardiac surgery