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CytoSorb for Cardiac Surgery (REFRESH II-AKI Trial)

N/A
Waitlist Available
Research Sponsored by CytoSorbents, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from start of cpb through 48 hours after cpb
Awards & highlights

Summary

This trial will compare the standard of care to the standard of care plus a new device called the CytoSorb®. The study will enroll patients who are randomly assigned to either treatment group. The study will be "blinded" meaning that neither the patients nor the study staff will know which treatment each patient is receiving.

Eligible Conditions
  • Cardiac Surgery

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from start of cpb through 48 hours after cpb
This trial's timeline: 3 weeks for screening, Varies for treatment, and from start of cpb through 48 hours after cpb for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence or severity of acute kidney injury (AKI) in the first 48 hours after cardiopulmonary pulmonary bypass (CPB)
Secondary outcome measures
Change in maximum plasma free hemoglobin and activated complement from start of CPB through post-surgery day 3
Severity or duration of AKI in the first 7 days after CPB

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: CytoSorb DeviceExperimental Treatment1 Intervention
Standard of care plus treatment with CytoSorb device installed on the Cardiopulmonary bypass (CPB) machine
Group II: ControlPlacebo Group1 Intervention
Standard of care
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CytoSorb
2016
Completed Phase 3
~230

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Who is running the clinical trial?

CytoSorbents, IncLead Sponsor
16 Previous Clinical Trials
4,909 Total Patients Enrolled
~16 spots leftby Sep 2025
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