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

Sponsor

CytoSorbents, Inc (Industry)

Overall Status

Terminated

CT.gov ID

NCT03384875

Collaborator

(none)

116

Enrollment

Locations

Arms

Actual Duration (Months)

5.8

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Elective Cardiac Surgery	Device: CytoSorb	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

116 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 :

Apr 19, 2018

Actual Primary Completion Date :

Jan 18, 2022

Actual Study Completion Date :

Jan 18, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CytoSorb Device Standard of care plus treatment with CytoSorb device installed on the Cardiopulmonary bypass (CPB) machine	Device: CytoSorb To evaluate the safety and performance of the CytoSorb® device to decrease the incidence or severity of acute kidney injury (AKI) Other Names: 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 Names: CytoSorb device used during cardiopulmonary bypass (CPB)

Arm

Intervention/Treatment

Experimental: CytoSorb Device

Standard of care plus treatment with CytoSorb device installed on the Cardiopulmonary bypass (CPB) machine

Device: CytoSorb

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

Other Names:

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 Names:

CytoSorb device used during cardiopulmonary bypass (CPB)

Outcome Measures

Primary Outcome Measures

Incidence or severity of acute kidney injury (AKI) in the first 48 hours after cardiopulmonary pulmonary bypass (CPB) [From start of CPB through 48 hours after CPB]
Kidney Disease Improving Global Outcomes (KDIGO) definitions for AKI

Secondary Outcome Measures

Change in maximum plasma free hemoglobin and activated complement from start of CPB through post-surgery day 3 [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 [From start of CPB through 7 days post-cardiac surgery]
KDIGO definitions for AKI

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yale School of Medicine	New Haven	Connecticut	United States	06510
2	University of Chicago	Chicago	Illinois	United States	60637
3	Indiana University Health Methodist Hospital	Indianapolis	Indiana	United States	46202
4	Iowa Heart Center	West Des Moines	Iowa	United States	50266
5	University of Louisville	Louisville	Kentucky	United States	40202
6	Maine Medical Center	Portland	Maine	United States	04102
7	University of Maryland	Baltimore	Maryland	United States	21201
8	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115
9	Valley Hospital	Ridgewood	New Jersey	United States	07450
10	Columbia University Medical Center	New York	New York	United States	10032
11	Northwell Health: Lennox Hill Hospital	New York	New York	United States	10075
12	Duke University Medical Center	Durham	North Carolina	United States	27710
13	East Carolina University	Greenville	North Carolina	United States	27858
14	The Christ Hospital Linder Research Center	Cincinnati	Ohio	United States	45219
15	Ohio State university	Columbus	Ohio	United States	43210
16	Integris Baptist Medical Center	Oklahoma City	Oklahoma	United States	73112
17	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
18	Baptist Memorial Hospital	Memphis	Tennessee	United States	38120
19	Vanderbilt University	Nashville	Tennessee	United States	37212
20	Baylor College of Medicine	Houston	Texas	United States	77030