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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03384875
Recruitment Status : Recruiting
First Posted : December 28, 2017
Last Update Posted : January 10, 2019
Information provided by (Responsible Party):
CytoSorbents, Inc

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 Not Applicable

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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 : August 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

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 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)

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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

  2. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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

Information from the National Library of Medicine

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 identifier (NCT number): NCT03384875

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Contact: Sally Palmer 732-398-5442
Contact: Rita Paparazzo, MBA 508-691-7032

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United States, Connecticut
Yale School of Medicine Recruiting
New Haven, Connecticut, United States, 06510
Contact: Lynn Wilson    203-737-8871      
Principal Investigator: Arnar Geirsson, MD         
United States, Indiana
Indiana University Health Methodist Hospital Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Terri Strickland    317-962-3586      
Principal Investigator: Joel Corvera, MD         
St. Vincent Heart Center Recruiting
Indianapolis, Indiana, United States, 46290
Contact: Jana Fisher    317-583-7804      
Principal Investigator: Sina Moainie, MD         
United States, Kentucky
University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
Contact: Anne Marie Webb, RN    502-587-4106      
Principal Investigator: Kristen Sell-Dottin, MD         
United States, Maine
Maine Medical Center Recruiting
Portland, Maine, United States, 04102
Contact: Betsey Gallant, RN    207-662-1489      
Principal Investigator: Scott Buchanan, MD         
United States, Maryland
University of Maryland Recruiting
Baltimore, Maryland, United States, 21201
Contact: Kendra Petrick    410-328-4505      
Principal Investigator: Ken Tanaka, MD         
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: James Gosnell    617-732-5500 ext 33274      
Principal Investigator: Nascimben Luigi, MD         
United States, New Jersey
Cooper University Hospital Recruiting
Camden, New Jersey, United States, 08103
Contact: Brian McEniry    856-968-7333      
Principal Investigator: Kinjal Patel, MD         
United States, New York
Northwell Health: North Shore University Hospital Recruiting
Manhasset, New York, United States, 11030
Contact: Kristine McGowan    516-562-2345      
Principal Investigator: Brian Lima, MD         
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Natasha Desai    212-305-3009      
Principal Investigator: Michael Argenziano, MD         
Northwell Health: Lennox Hill Hospital Recruiting
New York, New York, United States, 10075
Contact: Efstathia Mihelis    212-434-6614      
Principal Investigator: Nirav Patel, MD         
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Peter Waweru, CCRP    919-681-4058      
Principal Investigator: Ian Welsby, MD         
United States, Ohio
The Christ Hospital Linder Research Center Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Patricia Padgett    513-585-1778      
Principal Investigator: Geoffrey Answini, MD         
United States, Oklahoma
Integris Baptist Medical Center Recruiting
Oklahoma City, Oklahoma, United States, 73112
Contact: Emily Ferguson    405-951-8217      
Principal Investigator: David Vanhooser, MD         
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Josue Estrella    215-662-2017      
Principal Investigator: Joseph Bavaria, MD         
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15261
Contact: MIchelle Mackay, RN    412-623-2809      
Principal Investigator: Forozan Navid, MD         
United States, Tennessee
Baptist Memorial Hospital Recruiting
Memphis, Tennessee, United States, 38120
Contact: Vanessa Derrick    901-226-1689      
Principal Investigator: Edward Garett, MD         
Vanderbilt University Recruiting
Nashville, Tennessee, United States, 37212
Contact: Norma Suazo Galeano    615-875-1727      
Principal Investigator: Clayton Kaiser, MD         
United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Luis Risquet    832-355-9942      
Principal Investigator: Scott LeMaire, MD         
Sponsors and Collaborators
CytoSorbents, Inc

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Responsible Party: CytoSorbents, Inc Identifier: NCT03384875     History of Changes
Other Study ID Numbers: 2017-001
First Posted: December 28, 2017    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: October 2018

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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

Keywords provided by CytoSorbents, Inc:
CytoSorb device
Plasma free hemoglobin
extracorporeal cardiopulmonary bypass
cardiopulmonary bypass
Acute Kidney Injury

Additional relevant MeSH terms:
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Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases