Elective Cardiac SurgeryREFRESH II-AKINCT03384875
CytoSorb® Reduction of FREee Hemoglobin/Acute Kidney Injury (AKI) During Cardiac Surgery
A study testing CytoSorb in people with Elective Cardiac Surgery, run by CytoSorbents, Inc at 20 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Elective Cardiac Surgery
- What is being tested?
- CytoSorb
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 186 participants
- Where
- 20 sitesUnited States
- Study dates
- 19 Apr 2018to 18 Jan 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Isolated Coronary Artery Bypass Graft
- Pregnant women
- Life expectancy of < 14 days
- End stage organ disease
- Active infection
- Correction of a congenital heart defect
Show all 9Show fewer
- Contraindication to anticoagulation with heparin
- Minimally invasive surgery implantation (TAVI) or transcatheter aortic valve replacement (TAVR)
- Declined informed consent
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
University of Maryland
Baltimore, Maryland, 21201
Brigham and Women's Hospital
Boston, Massachusetts, 02115
University of Chicago
Chicago, Illinois, 60637
The Christ Hospital Linder Research Center
Cincinnati, Ohio, 45219
Ohio State university
Columbus, Ohio, 43210
Duke University Medical Center
Durham, North Carolina, 27710
East Carolina University
Greenville, North Carolina, 27858
Baylor College of Medicine
Houston, Texas, 77030
Indiana University Health Methodist Hospital
Indianapolis, Indiana, 46202
University of Louisville
Louisville, Kentucky, 40202
Baptist Memorial Hospital
Memphis, Tennessee, 38120
Vanderbilt University
Nashville, Tennessee, 37212
Yale School of Medicine
New Haven, Connecticut, 06510
Columbia University Medical Center
New York, New York, 10032
Northwell Health: Lennox Hill Hospital
New York, New York, 10075
Integris Baptist Medical Center
Oklahoma City, Oklahoma, 73112
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Maine Medical Center
Portland, Maine, 04102
Valley Hospital
Ridgewood, New Jersey, 07450
Iowa Heart Center
West Des Moines, Iowa, 50266
About this study
Official title: CytoSorb® Reduction of FREee Hemoglobin/Acute Kidney Injury (AKI) During Cardiac Surgery (REFRESH II Trial)
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.
Read the detailed description
To evaluate the safety and performance of the CytoSorb® device to decrease the incidence or severity of acute kidney injury (AKI) as defined by Kidney Disease Improving Global Outcomes (KDIGO) clinical practice guideline definition of acute kidney injury when used intraoperatively with cardiopulmonary bypass (CPB) in subjects undergoing cardiac surgery. The objective of using CytoSorb® treatment in this setting is to provide clinically meaningful improvements in renal function by mitigation of intraoperative injury by removal of nephrotoxic agents such as pfHb and complement. Up to 420 subjects will be enrolled and randomized at a 1:1 ratio at up to 40 investigational sites in the United States.
- Conditions
- Elective Cardiac Surgery
- Being tested
- CytoSorb
- Keywords
- CytoSorb device, Plasma free hemoglobin, inflammation, extracorporeal cardiopulmonary bypass, cardiopulmonary bypass, Acute Kidney Injury
- Medical subject headings
- Inflammation, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CytoSorbDevice
Also called CytoSorb device used during cardiopulmonary bypass (CPB)
To evaluate the safety and performance of the CytoSorb® device to decrease the incidence or severity of acute kidney injury (AKI)
| Study group | Role | What they receive |
|---|---|---|
| CytoSorb Device | Experimental | Standard of care plus treatment with CytoSorb device installed on the Cardiopulmonary bypass (CPB) machine Receives: Device: CytoSorb |
| Control | Placebo comparator | Standard of care Receives: Device: CytoSorb |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and Severity of Acute Kidney Injury (AKI) in the First 48 Hours After Cardiopulmonary Pulmonary Bypass (CPB)
Incidence and severity of AKI in the first 48 hours after CPB, evaluated based on creatinine levels at CPB, 24 \& 48h after CPB and urine output up to 48h.
Measured: From start of CPB through 48 hours after CPB
Secondary outcomes (5)
Summary of Health Resource Utilization: ICU Duration (Hours)
Analysis of health resource utilization included parameters such as length of stay in ICU and hospital and need for supportive care measures such as vasopressors, and mechanical ventilation.
Measured: From start of CPB through discharge, average of 8.9 days.
Summary of Health Resource Utilization: Post-Op Hospital Stay: Date of Discharge - Date of ICU Admission
Analysis of health resource utilization included parameters such as length of stay in ICU and hospital and need for supportive care measures such as vasopressors, and mechanical ventilation.
Measured: From start of CPB through discharge, average of 8.9 days.
Summary of Health Resource Utilization: Number of Patients on Vasopressor Medication
Analysis of health resource utilization included parameters such as length of stay in ICU and hospital and need for supportive care measures such as vasopressors, and mechanical ventilation.
Measured: From start of CPB through discharge, average of 8.9 days.
Summary of Health Resource Utilization: Duration of Continuous Intra-op to Post-op Ventilator/ Mechanical Support Use
Analysis of health resource utilization included parameters such as length of stay in ICU and hospital and need for supportive care measures such as vasopressors, and mechanical ventilation.
Measured: From start of CPB through discharge, average of 8.9 days.
Initiation of Renal Replacement Therapy
Initiation of Renal Replacement Therapy up to 48 Hours post CPB
Measured: Up to 48 hours after CPB
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2017
- Study start19 Apr 2018
- Primary completion18 Jan 2022
- Study completion18 Jan 2022
Why it stopped: Sponsor's decision for business reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Elective Cardiac SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- CytoSorbents, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Gleason, MD, Principal investigator, not applicable- Unaffiliated with CytoSorbents
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03384875
- Sponsor's protocol ID
- 2017-001
- Acronym
- REFRESH II-AKI
- Status last verified
- Aug 2022
- First submitted
- 20 Dec 2017
- Last updated
- 4 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CytoSorb® Reduction of FREee Hemoglobin/Acute Kidney Injury (AKI) During Cardiac Surgery (REFRESH II Trial)
- ClinicalTrials.gov ID
- NCT03384875
- Acronym / sponsor ID
- REFRESH II-AKI / 2017-001
- Conditions
- Elective Cardiac Surgery
- Keywords
- CytoSorb device, Plasma free hemoglobin, inflammation, extracorporeal cardiopulmonary bypass, cardiopulmonary bypass, Acute Kidney Injury
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor's decision for business reasons
- Enrolment
- 186 participants (actual)
- Lead sponsor
- CytoSorbents, IncIndustry (pharma, biotech, devices)
- Study start
- 19 Apr 2018 (actual)
- Primary completion
- 18 Jan 2022 (actual)
- Study completion
- 18 Jan 2022 (actual)
- First posted
- 28 Dec 2017 (actual)
- Results
- Posted 4 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
To evaluate the safety and performance of the CytoSorb® device to decrease the incidence or severity of acute kidney injury (AKI) as defined by Kidney Disease Improving Global Outcomes (KDIGO) clinical practice guideline definition of acute kidney injury when used intraoperatively with cardiopulmonary bypass (CPB) in subjects undergoing cardiac surgery. The objective of using CytoSorb® treatment in this setting is to provide clinically meaningful improvements in renal function by mitigation of intraoperative injury by removal of nephrotoxic agents such as pfHb and complement. Up to 420 subjects will be enrolled and randomized at a 1:1 ratio at up to 40 investigational sites in the United States.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CytoSorb Device | Experimental | Device: CytoSorbStandard of care plus treatment with CytoSorb device installed on the Cardiopulmonary bypass (CPB) machine |
| Control | Placebo comparator | Device: CytoSorbStandard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (9 listed)
- Isolated Coronary Artery Bypass Graft
- Pregnant women
- Life expectancy of < 14 days
- End stage organ disease
- Active infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CytoSorbAlso: CytoSorb device used during cardiopulmonary bypass (CPB)To evaluate the safety and performance of the CytoSorb® device to decrease the incidence or severity of acute kidney injury (AKI) | Device | Control, CytoSorb Device |
Primary outcome
Incidence and 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
Incidence and severity of AKI in the first 48 hours after CPB, evaluated based on creatinine levels at CPB, 24 \& 48h after CPB and urine output up to 48h.
5 secondary outcomes
Summary of Health Resource Utilization: ICU Duration (Hours)
Time frame: From start of CPB through discharge, average of 8.9 days.
Summary of Health Resource Utilization: Post-Op Hospital Stay: Date of Discharge - Date of ICU Admission
Time frame: From start of CPB through discharge, average of 8.9 days.
Summary of Health Resource Utilization: Number of Patients on Vasopressor Medication
Time frame: From start of CPB through discharge, average of 8.9 days.
Summary of Health Resource Utilization: Duration of Continuous Intra-op to Post-op Ventilator/ Mechanical Support Use
Time frame: From start of CPB through discharge, average of 8.9 days.
Initiation of Renal Replacement Therapy
Time frame: Up to 48 hours after CPB
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Gleason, MD principal investigator
not applicable- Unaffiliated with CytoSorbents
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CytoSorb in people with Elective Cardiac Surgery, run by CytoSorbents, Inc at 20 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2024.