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Terminated Not applicable Interventional Results available

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

ClinicalTrials.gov ID: NCT03384875

Public ClinicalTrials.gov record NCT03384875. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 22, 2026, 7:29 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT03384875
Recruitment status
Terminated
Study type
Interventional
Phase
Not applicable
Lead sponsor
CytoSorbents, Inc
Industry
Enrollment
186 participants

Conditions and interventions

Interventions

Device

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 19, 2018 (Actual)
Primary completion
Jan 18, 2022 (Actual)
Completion
Jan 18, 2022 (Actual)
Last update posted
Dec 4, 2024

2018 – 2022

United States locations

U.S. sites
20
U.S. states
16
U.S. cities
19
Facility City State ZIP Site status
Yale School of Medicine New Haven Connecticut 06510 —
University of Chicago Chicago Illinois 60637 —
Indiana University Health Methodist Hospital Indianapolis Indiana 46202 —
Iowa Heart Center West Des Moines Iowa 50266 —
University of Louisville Louisville Kentucky 40202 —
Maine Medical Center Portland Maine 04102 —
University of Maryland Baltimore Maryland 21201 —
Brigham and Women's Hospital Boston Massachusetts 02115 —
Valley Hospital Ridgewood New Jersey 07450 —
Columbia University Medical Center New York New York 10032 —
Northwell Health: Lennox Hill Hospital New York New York 10075 —
Duke University Medical Center Durham North Carolina 27710 —
East Carolina University Greenville North Carolina 27858 —
The Christ Hospital Linder Research Center Cincinnati Ohio 45219 —
Ohio State university Columbus Ohio 43210 —
Integris Baptist Medical Center Oklahoma City Oklahoma 73112 —
University of Pennsylvania Philadelphia Pennsylvania 19104 —
Baptist Memorial Hospital Memphis Tennessee 38120 —
Vanderbilt University Nashville Tennessee 37212 —
Baylor College of Medicine Houston Texas 77030 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03384875, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Dec 4, 2024 · Synced Oct 22, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03384875 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →