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

Not Applicable

Terminated

• Conditions: Elective Cardiac Surgery
• Interventions: Device: CytoSorb

• Registration Number: NCT03384875
• Lead Sponsor: CytoSorbents, Inc

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.

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 Timeline

• Study First Submitted: 2017-12-20
• Study First Submitted QC: 2017-12-20
• Study First Posted: 2017-12-28
• Study Start: 2018-04-19
• Primary Completion: 2022-01-18
• Study Completion: 2022-01-18
• Status Verified: 2022-08
• Results First Submitted: 2024-04-09
• Results First Submitted QC: 2024-11-12
• Last Update Submitted: 2024-11-12
• Results First Posted: 2024-12-04
• Last Update Posted: 2024-12-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 186

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CytoSorb Device	CytoSorb	Standard of care plus treatment with CytoSorb device installed on the Cardiopulmonary bypass (CPB) machine
Control	CytoSorb	Standard of care

Primary Outcome Measures

Name	Time	Method
Incidence and Severity of Acute Kidney Injury (AKI) in the First 48 Hours After Cardiopulmonary Pulmonary Bypass (CPB)	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.

Secondary Outcome Measures

Name	Time	Method
Summary of Health Resource Utilization: ICU Duration (Hours)	From start of CPB through discharge, average of 8.9 days.	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.
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.	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.
Summary of Health Resource Utilization: Number of Patients on Vasopressor Medication	From start of CPB through discharge, average of 8.9 days.	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.
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.	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.
Initiation of Renal Replacement Therapy	Up to 48 hours after CPB	Initiation of Renal Replacement Therapy up to 48 Hours post CPB

Trial Locations

Locations (20)

Yale School of Medicine; 🇺🇸 New Haven, Connecticut, United States

Baptist Memorial Hospital; 🇺🇸 Memphis, Tennessee, United States

Ohio State university; 🇺🇸 Columbus, Ohio, United States

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States

Integris Baptist Medical Center; 🇺🇸 Oklahoma City, Oklahoma, United States

University of Chicago; 🇺🇸 Chicago, Illinois, United States

Indiana University Health Methodist Hospital; 🇺🇸 Indianapolis, Indiana, United States

Iowa Heart Center; 🇺🇸 West Des Moines, Iowa, United States

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

Valley Hospital; 🇺🇸 Ridgewood, New Jersey, United States

Maine Medical Center; 🇺🇸 Portland, Maine, United States

University of Maryland; 🇺🇸 Baltimore, Maryland, United States

Columbia University Medical Center; 🇺🇸 New York, New York, United States

Northwell Health: Lennox Hill Hospital; 🇺🇸 New York, New York, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

The Christ Hospital Linder Research Center; 🇺🇸 Cincinnati, Ohio, United States

University of Louisville; 🇺🇸 Louisville, Kentucky, United States

East Carolina University; 🇺🇸 Greenville, North Carolina, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Vanderbilt University; 🇺🇸 Nashville, Tennessee, United States