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

CytoSorbents

Status: Terminated

Conditions: Elective Cardiac Surgery

Treatments: Device: CytoSorb

Study type: Interventional

Funder types: Industry

Identifiers

NCT03384875

2017-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 186 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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186 participants in 2 patient groups, including a placebo group

CytoSorb Device

Experimental group

Description:

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

Treatment:

Device: CytoSorb

Control

Placebo Comparator group

Description:

Standard of care

Treatment:

Device: CytoSorb