NCT03384875

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 186 (actual)
• Sponsor: CytoSorbents, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Elective Cardiac Surgery

Interventions

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

Timeline

• Start date: 2018-04-19
• Primary completion: 2022-01-18
• Completion: 2022-01-18
• First posted: 2017-12-28
• Last updated: 2024-12-04
• Results posted: 2024-12-04

Locations

20 sites across 1 country: United States

Regulatory

• FDA-regulated device study