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History of Changes for Study: NCT03384875
CytoSorb® Reduction of FREee Hemoglobin/Acute Kidney Injury (AKI) During Cardiac Surgery
Latest version (January 9, 2019) on ClinicalTrials.gov
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Study Record Versions
Version A B Date Changes
1 December 20, 2017 Nothing (earliest Version on record)
2 January 8, 2018 Study Status
3 January 15, 2018
Recruitment Status
, Study Status, Sponsor/Collaborators, Study Identification, Contacts/Locations, Eligibility, Outcome Measures, Arms and Interventions, Study Design, Conditions, Study Description and Oversight
4 April 20, 2018
Recruitment Status
, Contacts/Locations, Study Status and Oversight
5 May 2, 2018 Outcome Measures, Eligibility and Study Status
6 June 5, 2018 Contacts/Locations and Study Status
7 July 16, 2018 Contacts/Locations and Study Status
8 July 24, 2018 Study Status and Contacts/Locations
9 August 17, 2018 Study Status and Contacts/Locations
10 September 6, 2018 Contacts/Locations, Eligibility and Study Status
11 October 1, 2018 Contacts/Locations and Study Status
12 October 12, 2018 Study Status and Contacts/Locations
13 October 29, 2018 Contacts/Locations and Study Status
14 November 1, 2018 Contacts/Locations and Study Status
15 November 26, 2018 Contacts/Locations and Study Status
16 November 30, 2018 Contacts/Locations and Study Status
17 December 17, 2018 Study Status and Contacts/Locations
18 December 20, 2018 Study Status and Contacts/Locations
19 January 9, 2019 Contacts/Locations and Study Status
Comparison Format:

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Changes (Side-by-Side) for Study: NCT03384875
April 20, 2018 (v4) -- November 1, 2018 (v14)

Changes in: Contacts/Locations, Outcome Measures, Eligibility and Study Status

Study Identification
Unique Protocol ID: 2017-001 2017-001
Brief Title: CytoSorb® Reduction of FREee Hemoglobin/Acute Kidney Injury (AKI) During Cardiac Surgery (REFRESH II-AKI)CytoSorb® Reduction of FREee Hemoglobin/Acute Kidney Injury (AKI) During Cardiac Surgery (REFRESH II-AKI)
Official Title: CytoSorb® Reduction of FREee Hemoglobin/Acute Kidney Injury (AKI) During Cardiac Surgery (REFRESH II Trial) CytoSorb® Reduction of FREee Hemoglobin/Acute Kidney Injury (AKI) During Cardiac Surgery (REFRESH II Trial)
Secondary IDs:
Study Status
Record Verification: April 2018 October 2018
Overall Status: Recruiting Recruiting
Study Start: April 19, 2018 April 19, 2018
Primary Completion: August 2020 [Anticipated ] August 2020 [Anticipated ]
Study Completion: October 2020 [Anticipated ] October 2020 [Anticipated ]
First Submitted: December 20, 2017 December 20, 2017
First Submitted that
Met QC Criteria:
December 20, 2017 December 20, 2017
First Posted: December 28, 2017 [Actual ] December 28, 2017 [Actual ]
Last Update Submitted that
Met QC Criteria:
April 20, 2018 November 1, 2018
Last Update Posted: April 24, 2018 [Actual ] November 2, 2018 [Actual ]
Sponsor/Collaborators
Sponsor: CytoSorbents, Inc CytoSorbents, Inc
Responsible Party: Sponsor Sponsor
Collaborators:
Oversight
U.S. FDA-regulated Drug: No No
U.S. FDA-regulated Device: Yes Yes
Unapproved/Uncleared Device:
Pediatric Postmarket Surveillance:
Data Monitoring:
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. 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.
Detailed Description:
Conditions
Conditions: Elective Cardiac Surgery Elective Cardiac Surgery
Keywords: CytoSorb device
Plasma free hemoglobin
inflammation
extracorporeal cardiopulmonary bypass
cardiopulmonary bypass
Acute Kidney Injury
CytoSorb device
Plasma free hemoglobin
inflammation
extracorporeal cardiopulmonary bypass
cardiopulmonary bypass
Acute Kidney Injury
Study Design
Study Type: InterventionalInterventional
Primary Purpose: TreatmentTreatment
Study Phase: Not ApplicableNot Applicable
Interventional Study Model: Parallel Assignment Parallel Assignment
Number of Arms: 22
Masking: TripleParticipant, Care Provider, InvestigatorTripleParticipant, Care Provider, Investigator
Allocation: RandomizedRandomized
Enrollment: 400 [Anticipated ] 400 [Anticipated ]
Arms and Interventions
Arms Assigned Interventions
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:
1. Assess the incidence of Acute Kidney Injury (AKI) in the first 48 hours after surgery when used intra-operatively with cardiopulmonary pulmonary bypass (CPB)
Kidney Disease: Improving Global Outcomes (KDIGO) Clinical Practice Guideline will be used to arrive at one reported value for AKI.

[Time Frame: First 48 hours after cardiopulmonary bypass procedure ]
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

[Time Frame: From start of CPB through 48 hours after CPB ]
Secondary Outcome Measures:
2. Evaluate change and/or difference in maximum plasma free hemoglobin and complement protein with CytoSorb versus control
Blood Samples

[Time Frame: From start of cardiopulmonary bypass procedure and end of cardiopulmonary bypass and 3 days post surgery ]
3. Serum creatinine
Blood Samples

[Time Frame: Collected for 7 days post-cardiac surgery ]
4. Urine Output

[Time Frame: From end of cardiopulmonary bypass and 3 days post surgery ]
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

[Time Frame: From start of CPB through post-surgery day 3 ]
5. Incidence/progression of Acute Kidney Injury
Blood

[Time Frame: From Baseline through 7 days post-cardiac surgery ]
Severity or duration of AKI in the first 7 days after CPB
KDIGO definitions for AKI

[Time Frame: From start of CPB through 7 days post-cardiac surgery ]
Eligibility
Minimum Age: 18 Years 18 Years
Maximum Age: 80 Years
Sex: All All
Gender Based:
Accepts Healthy Volunteers: NoNo
Criteria:

Inclusion Criteria:

  • Scheduled for non-emergent open heart valve replacement surgery or aortic reconstruction requiring requiring hypothermic arrest, requiring cardiopulmonary bypass

Exclusion Criteria:

  • Weight < 99 lbs - > 383 lbs
  • Isolated Coronary 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

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
Contacts/Locations
Central Contact: Sally Palmer
Telephone: 732-398-5442
Email: spalmer@cytosorbents.com
Sally Palmer
Telephone: 732-398-5442
Email: spalmer@cytosorbents.com
Central Contact Backup: Hilary Jordan Dion, PA, BA
Telephone: 508 691 7020
Email: hjordan@boston-biomedical.com
Rita Paparazzo, MBA
Telephone: 508-691-7032
Email: rpaparazzo@boston-biomedical.com
Locations: 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, 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
United States, New York
Presbyterian Hospital Columbia University Medical Center
[Recruiting]
New York, New York, United States, 10032
Contact: Lyn Goldsmith, RN
Principal Investigator: Argenziano, 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, 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, Texas
Baylor College of Medicine
[Recruiting]
Houston, Texas, United States, 77030
Contact: Luis Risquet 832-355-9942
Principal Investigator: Scott LeMaire, MD
IPDSharing
Plan to Share IPD:
References
Citations:
Links:
Available IPD/Information:

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