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

NCT ID: NCT03384875

Last Updated: 2024-12-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

186 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-19

Study Completion Date

2022-01-18

Brief Summary

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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

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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

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Elective Cardiac Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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CytoSorb Device

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

Group Type EXPERIMENTAL

CytoSorb

Intervention Type DEVICE

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

Control

Standard of care

Group Type PLACEBO_COMPARATOR

CytoSorb

Intervention Type DEVICE

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

Interventions

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CytoSorb

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

Intervention Type DEVICE

Other Intervention Names

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CytoSorb device used during cardiopulmonary bypass (CPB)

Eligibility Criteria

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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

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CytoSorbents, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas Gleason, MD

Role: PRINCIPAL_INVESTIGATOR

not applicable- Unaffiliated with CytoSorbents

Locations

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Yale School of Medicine

New Haven, Connecticut, United States

Site Status

University of Chicago

Chicago, Illinois, United States

Site Status

Indiana University Health Methodist Hospital

Indianapolis, Indiana, United States

Site Status

Iowa Heart Center

West Des Moines, Iowa, United States

Site Status

University of Louisville

Louisville, Kentucky, United States

Site Status

Maine Medical Center

Portland, Maine, United States

Site Status

University of Maryland

Baltimore, Maryland, United States

Site Status

Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Valley Hospital

Ridgewood, New Jersey, United States

Site Status

Columbia University Medical Center

New York, New York, United States

Site Status

Northwell Health: Lennox Hill Hospital

New York, New York, United States

Site Status

Duke University Medical Center

Durham, North Carolina, United States

Site Status

East Carolina University

Greenville, North Carolina, United States

Site Status

The Christ Hospital Linder Research Center

Cincinnati, Ohio, United States

Site Status

Ohio State university

Columbus, Ohio, United States

Site Status

Integris Baptist Medical Center

Oklahoma City, Oklahoma, United States

Site Status

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Baptist Memorial Hospital

Memphis, Tennessee, United States

Site Status

Vanderbilt University

Nashville, Tennessee, United States

Site Status

Baylor College of Medicine

Houston, Texas, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2017-001

Identifier Type: -

Identifier Source: org_study_id