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

Primary Purpose

Elective Cardiac Surgery

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CytoSorb
Sponsored by
CytoSorbents, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Elective Cardiac Surgery focused on measuring CytoSorb device, Plasma free hemoglobin, inflammation, extracorporeal cardiopulmonary bypass, cardiopulmonary bypass, Acute Kidney Injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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 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

Sites / Locations

  • Yale School of Medicine
  • University of Chicago
  • Indiana University Health Methodist Hospital
  • Iowa Heart Center
  • University of Louisville
  • Maine Medical Center
  • University of Maryland
  • Brigham and Women's Hospital
  • Valley Hospital
  • Columbia University Medical Center
  • Northwell Health: Lennox Hill Hospital
  • Duke University Medical Center
  • East Carolina University
  • The Christ Hospital Linder Research Center
  • Ohio State university
  • Integris Baptist Medical Center
  • University of Pennsylvania
  • Baptist Memorial Hospital
  • Vanderbilt University
  • Baylor College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

CytoSorb Device

Control

Arm Description

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

Standard of care

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Severity or duration of AKI in the first 7 days after CPB
KDIGO definitions for AKI

Full Information

First Posted
December 20, 2017
Last Updated
August 8, 2022
Sponsor
CytoSorbents, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT03384875
Brief Title
CytoSorb® Reduction of FREee Hemoglobin/Acute Kidney Injury (AKI) During Cardiac Surgery
Acronym
REFRESH II-AKI
Official Title
CytoSorb® Reduction of FREee Hemoglobin/Acute Kidney Injury (AKI) During Cardiac Surgery (REFRESH II Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Terminated
Why Stopped
Sponsor's decision for business reasons
Study Start Date
April 19, 2018 (Actual)
Primary Completion Date
January 18, 2022 (Actual)
Study Completion Date
January 18, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CytoSorbents, Inc

4. Oversight

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

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Elective Cardiac Surgery
Keywords
CytoSorb device, Plasma free hemoglobin, inflammation, extracorporeal cardiopulmonary bypass, cardiopulmonary bypass, Acute Kidney Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
116 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Yale School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Indiana University Health Methodist Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Iowa Heart Center
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Maine Medical Center
City
Portland
State/Province
Maine
ZIP/Postal Code
04102
Country
United States
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Valley Hospital
City
Ridgewood
State/Province
New Jersey
ZIP/Postal Code
07450
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Northwell Health: Lennox Hill Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
East Carolina University
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27858
Country
United States
Facility Name
The Christ Hospital Linder Research Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Ohio State university
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Integris Baptist Medical Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Baptist Memorial Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

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

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