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TerminatedNCT03384875REFRESH II-AKIUpdated Dec 4, 2024Results posted

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

An interventional study of CytoSorb in Elective Cardiac Surgery, sponsored by CytoSorbents, Inc. Terminated at 20 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-04.

Primary conditionAcute Kidney InjuryRegistry: InflammationReclassifiedWhy we changed it
Registry
Inflammation — the first condition term the registry derived for this study.
ClinicalTrials.gg
Acute Kidney Injury
Why
  1. Inflammation is a broad heading, used only when no more specific condition is named.
  2. The study's title name Acute Kidney Injury.
Confidence
High: the new condition is named in the study's own title. Of 46 hand-checked studies reclassified this way, 72% were exactly right and 89% in the right disease family; the registry's first term was right for 4% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by CytoSorbents, Inc · Not applicable, Interventional, and Treatment

Why this study was terminated
Sponsor's decision for business reasons
Phase
Not applicable
Study type
Interventional
Enrollment
186
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Elective Cardiac Surgery

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Keywords

  • CytoSorb device
  • Plasma free hemoglobin
  • inflammation
  • extracorporeal cardiopulmonary bypass
  • cardiopulmonary bypass
  • Acute Kidney Injury
03

In context

Acute Kidney Injury Reclassified

1,691 studies on the registry are indexed under Acute Kidney Injury; 395 are open to participants now.

This study's enrollment of 186 is above the median of 100 across 817 interventional studies indexed under Acute Kidney Injury.

Browse Acute Kidney Injury studies →

Lead sponsor

CytoSorbents, Inc is the lead sponsor of 9 studies on the registry; 1 is open to participants now.

Compared within Acute Kidney Injury, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Inflammation. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Isolated Coronary Artery Bypass Graft
  • Pregnant women
  • of \< 14 days
  • End stage organ disease
  • Active infection
  • Correction of a congenital heart defect
  • to anticoagulation with heparin
  • Minimally invasive surgery implantation (TAVI) or transcatheter aortic valve replacement (TAVR)
  • Declined
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
186 participants (actual)

Study arms

  • Experimental
    CytoSorb Device

    Standard of care plus treatment with CytoSorb device installed on the Cardiopulmonary bypass (CPB) machine

    Device: CytoSorb

  • Placebo comparator
    Control

    Standard of care

    Device: CytoSorb

Interventions

  • DeviceCytoSorb

    To evaluate the safety and performance of the CytoSorb® device to decrease the incidence or severity of acute kidney injury (AKI)

    Also known as: CytoSorb device used during cardiopulmonary bypass (CPB)

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: From start of CPB through 48 hours after CPB

Secondary outcomes

  1. 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.

    Time frame: From start of CPB through discharge, average of 8.9 days.

  2. 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.

    Time frame: From start of CPB through discharge, average of 8.9 days.

  3. 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.

    Time frame: From start of CPB through discharge, average of 8.9 days.

  4. 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.

    Time frame: From start of CPB through discharge, average of 8.9 days.

  5. Initiation of Renal Replacement Therapy

    Initiation of Renal Replacement Therapy up to 48 Hours post CPB

    Time frame: Up to 48 hours after CPB

07

Results

Posted Dec 4, 2024
Limitations and caveats
Early termination leading to small numbers of subjects analyzed.

Participant flow

Participant flow — Overall Study
MilestoneCytoSorb DeviceControlRoll in: SOC + CytoSorb Device
Started566036
Completed545936
Not completed210
Withdrew: Death110
Withdrew: Reason not provided100

Outcome measures

PrimaryIncidence 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.

Time frame:
From start of CPB through 48 hours after CPB
Reported as:
Count of participants · Participants
Incidence and Severity of Acute Kidney Injury (AKI) in the First 48 Hours After Cardiopulmonary Pulmonary Bypass (CPB)
ParticipantsCytoSorb DeviceControlRoll In: CytoSorb Device
AKI Stage 09127
AKI Stage 1 (Mild)752
AKI Stage 2 (moderate)312821
AKI Stage 3 (Severe)9156
Statistical analysis
  • CytoSorb Device vs Control · Chi-squared · p = 0.517 · Risk difference (rd): 0
SecondarySummary 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.

Time frame:
From start of CPB through discharge, average of 8.9 days.
Reported as:
Median · hours
Summary of Health Resource Utilization: ICU Duration (Hours)
hoursCytoSorb DeviceControlRoll in: SOC + CytoSorb Device
Summary of Health Resource Utilization: ICU Duration (Hours)70.63 ± 85.5553.57 ± 67.6066.83 ± 132.87
SecondarySummary 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.

Time frame:
From start of CPB through discharge, average of 8.9 days.
Reported as:
Median · days
Summary of Health Resource Utilization: Post-Op Hospital Stay: Date of Discharge - Date of ICU Admission
daysCytoSorb DeviceControlRoll in: SOC + CytoSorb Device
Summary of Health Resource Utilization: Post-Op Hospital Stay: Date of Discharge - Date of ICU Admission8 ± 3.97 ± 4.77 ± 5.2
SecondarySummary 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.

Time frame:
From start of CPB through discharge, average of 8.9 days.
Reported as:
Count of participants · Participants
Summary of Health Resource Utilization: Number of Patients on Vasopressor Medication
ParticipantsCytoSorb DeviceControlRoll in: SOC + CytoSorb Device
Summary of Health Resource Utilization: Number of Patients on Vasopressor Medication444832
SecondarySummary 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.

Time frame:
From start of CPB through discharge, average of 8.9 days.
Reported as:
Median · hours
Summary of Health Resource Utilization: Duration of Continuous Intra-op to Post-op Ventilator/ Mechanical Support Use
hoursCytoSorb DeviceControlRoll in: SOC + CytoSorb Device
Summary of Health Resource Utilization: Duration of Continuous Intra-op to Post-op Ventilator/ Mechanical Support Use12.83 ± 19.1211.62 ± 60.3813.30 ± 77.73
SecondaryInitiation of Renal Replacement Therapy

Initiation of Renal Replacement Therapy up to 48 Hours post CPB

Time frame:
Up to 48 hours after CPB
Reported as:
Count of participants · Participants
Initiation of Renal Replacement Therapy
ParticipantsCytoSorb DeviceControlRoll In: CytoSorb Device
Initiation of Renal Replacement Therapy030

Adverse events

Collected over Adverse event data was collected from the time of Consent to 30 days post-procedure +/- 5 days.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
CytoSorb Device1/56 (1.8%)28/56 (50%)35/56 (62.5%)
Control1/60 (1.7%)21/60 (35%)44/60 (73.3%)
Roll in: SOC + CytoSorb Device0/36 (0%)14/36 (38.9%)30/36 (83.3%)
Most frequent serious events
Most frequent serious events
EventCytoSorb DeviceControlRoll in: SOC + CytoSorb Device
Anaemia postoperativeInjury, poisoning and procedural complications7/563/602/36
Atrial fibrillationCardiac disorders6/567/602/36
Atrioventricular block completeCardiac disorders5/561/602/36
Acute kidney injuryRenal and urinary disorders1/563/602/36
PneumothoraxRespiratory, thoracic and mediastinal disorders1/560/602/36
Respiratory failureRespiratory, thoracic and mediastinal disorders0/561/602/36
Pleural effusionRespiratory, thoracic and mediastinal disorders3/562/601/36
HypotensionVascular disorders3/561/600/36
Cardiogenic shockCardiac disorders2/563/601/36
Most frequent other events
Showing 10 of 18
Most frequent other events
EventCytoSorb DeviceControlRoll in: SOC + CytoSorb Device
ThrombocytopeniaBlood and lymphatic system disorders10/567/6010/36
Anaemia postoperativeInjury, poisoning and procedural complications10/566/609/36
LeukocytosisBlood and lymphatic system disorders2/569/601/36
HyperglycaemiaMetabolism and nutrition disorders4/563/605/36
Acute respiratory failureRenal and urinary disorders4/566/603/36
Cardiogenic shockCardiac disorders0/561/603/36
HypokalaemiaMetabolism and nutrition disorders2/561/603/36
Acute Kidney injuryRenal and urinary disorders1/562/603/36
Urinary retentionRenal and urinary disorders0/563/603/36
Sinus bradycardiaCardiac disorders0/560/602/36

Baseline characteristics

Age, Continuous
Age, Continuous(years)CytoSorb DeviceControlRoll In: CytoSorb DeviceTotal
Mean66.98 ± 11.8764.10 ± 11.8866.14 ± 11.8465.64 ± 11.86
Sex: Female, Male
Sex: Female, Male(Participants)CytoSorb DeviceControlRoll In: CytoSorb DeviceTotal
Female1818945
Male384227107
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)CytoSorb DeviceControlRoll In: CytoSorb DeviceTotal
Hispanic or Latino1203
Not Hispanic or Latino535732142
Unknown or Not Reported2147
Race (NIH/OMB)
Race (NIH/OMB)(Participants)CytoSorb DeviceControlRoll In: CytoSorb DeviceTotal
American Indian or Alaska Native0000
Asian1001
Native Hawaiian or Other Pacific Islander0000
Black or African American43310
White515631138
More than one race0112
Unknown or Not Reported0011
Region of Enrollment
Region of Enrollment(participants)CytoSorb DeviceControlRoll In: CytoSorb DeviceTotal
United States566036152
Smoking History
Smoking History(participants)CytoSorb DeviceControlRoll In: CytoSorb DeviceTotal
Current Smoker102315
Former Smoker19281663
Never Smoked27301774
08

Study locations

20 sites
  • Yale School of Medicine
    New Haven, Connecticut 06510, United States
  • University of Chicago
    Chicago, Illinois 60637, United States
  • Indiana University Health Methodist Hospital
    Indianapolis, Indiana 46202, United States
  • Iowa Heart Center
    West Des Moines, Iowa 50266, United States
  • University of Louisville
    Louisville, Kentucky 40202, United States
  • Maine Medical Center
    Portland, Maine 04102, United States
  • University of Maryland
    Baltimore, Maryland 21201, United States
  • Brigham and Women's Hospital
    Boston, Massachusetts 02115, United States
  • Valley Hospital
    Ridgewood, New Jersey 07450, United States
  • Columbia University Medical Center
    New York, New York 10032, United States
  • Northwell Health: Lennox Hill Hospital
    New York, New York 10075, United States
  • Duke University Medical Center
    Durham, North Carolina 27710, United States
  • East Carolina University
    Greenville, North Carolina 27858, United States
  • The Christ Hospital Linder Research Center
    Cincinnati, Ohio 45219, United States
  • Ohio State university
    Columbus, Ohio 43210, United States
  • Integris Baptist Medical Center
    Oklahoma City, Oklahoma 73112, United States
  • University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
  • Baptist Memorial Hospital
    Memphis, Tennessee 38120, United States
  • Vanderbilt University
    Nashville, Tennessee 37212, United States
  • Baylor College of Medicine
    Houston, Texas 77030, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Apr 2018 to primary completion in Jan 2022, 44 months.

Results were first posted in Dec 2024, 2 years 10 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 20, 2017
First posted
Dec 28, 2017
StartActual
Apr 19, 2018
Primary completionActual
Jan 18, 2022
CompletionActual
Jan 18, 2022
Results first posted
Dec 4, 2024
Last update
Dec 4, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 4, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03384875
Lead sponsor
CytoSorbents, Inc
Responsible party
Sponsor
First posted
Dec 28, 2017
Start date
Apr 19, 2018
Primary completion
Jan 18, 2022
Completion
Jan 18, 2022
Results posted
Dec 4, 2024
Last update
Dec 4, 2024

Study contacts

Thomas Gleason, MD
principal investigator · not applicable- Unaffiliated with CytoSorbents

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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