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

NCT03384875 | Terminated Results FDA Device

• 1 other identifier: 2017-001
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 20

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.

Conditions

Elective Cardiac Surgery

Keywords

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

Outcome Measures

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.

  From start of CPB through 48 hours after CPB

Secondary Outcomes (5)

• Summary of Health Resource Utilization: ICU Duration (Hours)

  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

  From start of CPB through discharge, average of 8.9 days.

• Summary of Health Resource Utilization: Number of Patients on Vasopressor Medication

  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

  From start of CPB through discharge, average of 8.9 days.

• Initiation of Renal Replacement Therapy

  Up to 48 hours after CPB

Study Arms (2)

CytoSorb Device

EXPERIMENTAL

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

Device: CytoSorb

Control

PLACEBO COMPARATOR

Standard of care

Device: CytoSorb

Interventions

CytoSorb DEVICE

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)

Control; CytoSorb Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CytoSorbents, Inc: lead

Study Sites (20)

Yale School of Medicine

New Haven, Connecticut, 06510, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Indiana University Health Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

Iowa Heart Center

West Des Moines, Iowa, 50266, United States

Location

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Maine Medical Center

Portland, Maine, 04102, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Valley Hospital

Ridgewood, New Jersey, 07450, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Northwell Health: Lennox Hill Hospital

New York, New York, 10075, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

East Carolina University

Greenville, North Carolina, 27858, United States

Location

The Christ Hospital Linder Research Center

Cincinnati, Ohio, 45219, United States

Location

Ohio State university

Columbus, Ohio, 43210, United States

Location

Integris Baptist Medical Center

Oklahoma City, Oklahoma, 73112, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Baptist Memorial Hospital

Memphis, Tennessee, 38120, United States

Location

Vanderbilt University

Nashville, Tennessee, 37212, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Inflammation; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed.

Results Point of Contact

• Title: Darlene Lambert-Christie/ Director, Clinical Operations
• Organization: Cytosorbents

DLambert-Christie@cytosorbents.com

732.822.3332

Study Officials

• Thomas Gleason, MD

  not applicable- Unaffiliated with CytoSorbents

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2017
• First Posted: December 28, 2017
• Study Start: April 19, 2018
• Primary Completion: January 18, 2022
• Study Completion: January 18, 2022
• Last Updated: December 4, 2024
• Results First Posted: December 4, 2024

Record last verified: 2022-08

Locations

US (20)