Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
ClinicalTrials.gov Identifier: NCT03384875
Recruitment Status : Recruiting
First Posted : December 28, 2017
Last Update Posted : April 3, 2019
Sponsor:
Information provided by (Responsible Party):
CytoSorbents, Inc

Tracking Information
First Submitted Date  ICMJE December 20, 2017
First Posted Date  ICMJE December 28, 2017
Last Update Posted Date April 3, 2019
Actual Study Start Date  ICMJE April 19, 2018
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 2, 2018)
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
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT03384875 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 2, 2018)
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CytoSorb® Reduction of FREee Hemoglobin/Acute Kidney Injury (AKI) During Cardiac Surgery
Official Title  ICMJE CytoSorb® Reduction of FREee Hemoglobin/Acute Kidney Injury (AKI) During Cardiac Surgery (REFRESH II Trial)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Elective Cardiac Surgery
Intervention  ICMJE 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)
Study Arms  ICMJE
  • Experimental: CytoSorb Device
    Standard of care plus treatment with CytoSorb device installed on the Cardiopulmonary bypass (CPB) machine
    Intervention: Device: CytoSorb
  • Placebo Comparator: Control
    Standard of care
    Intervention: Device: CytoSorb
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 15, 2018)
400
Original Enrollment  ICMJE Not Provided
Estimated Study Completion Date  ICMJE October 2020
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sally Palmer 732-398-5442 spalmer@cytosorbents.com
Contact: Ganiat Idris 508-351-8632 ext 224 gidris@bbacro.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03384875
Other Study ID Numbers  ICMJE 2017-001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party CytoSorbents, Inc
Study Sponsor  ICMJE CytoSorbents, Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account CytoSorbents, Inc
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP