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

CytoSorbents, Inc186 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

186

Conditions

Elective Cardiac Surgery

Interventions

CytoSorbDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (20)

Yale School of Medicine

New Haven, Connecticut, United States

University of Chicago

Outcomes

Primary Outcomes

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

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.

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.

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.

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.

Data from ClinicalTrials.gov

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