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

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ClinicalTrials.gov Identifier: NCT03384875
Recruitment Status : Suspended (DMC recommendation for collection of additional trial data)
First Posted : December 28, 2017
Last Update Posted : November 27, 2019
Sponsor:
Information provided by (Responsible Party):
CytoSorbents, Inc

Study Description
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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

Study Design
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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

Arms and Interventions
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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)


Outcome Measures
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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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT03384875


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Sponsors and Collaborators
CytoSorbents, Inc
More Information
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Responsible Party: CytoSorbents, Inc
ClinicalTrials.gov Identifier: NCT03384875     History of Changes
Other Study ID Numbers: 2017-001
First Posted: December 28, 2017    Key Record Dates
Last Update Posted: November 27, 2019
Last Verified: November 2019

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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
inflammation
 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