Clinical trial NCT03384875: CytoSorb® Reduction of FREee Hemoglobin/Acute Kidney Injury (AKI) During Cardiac Surgery
Official title: CytoSorb® Reduction of FREee Hemoglobin/Acute Kidney Injury (AKI) During Cardiac Surgery (REFRESH II Trial)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Elective Cardiac Surgery
Keywords: CytoSorb device
Plasma free hemoglobin
inflammation
extracorporeal cardiopulmonary bypass
cardiopulmonary bypass
Acute Kidney Injury
Lead sponsor: CytoSorbents, Inc
Sponsor class: INDUSTRY
First posted: 2017-12-28
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence and Severity of Acute Kidney Injury (AKI) in the First 48 Hours After Cardiopulmonary Pulmonary Bypass (CPB)
timeFrame: From start of CPB through 48 hours after CPB
Secondary outcomes:
measure: Summary of Health Resource Utilization: ICU Duration (Hours)
timeFrame: From start of CPB through discharge, average of 8.9 days.
measure: Summary of Health Resource Utilization: Post-Op Hospital Stay: Date of Discharge - Date of ICU Admission
timeFrame: From start of CPB through discharge, average of 8.9 days.
measure: Summary of Health Resource Utilization: Number of Patients on Vasopressor Medication
timeFrame: From start of CPB through discharge, average of 8.9 days.
measure: Summary of Health Resource Utilization: Duration of Continuous Intra-op to Post-op Ventilator/ Mechanical Support Use
timeFrame: From start of CPB through discharge, average of 8.9 days.
measure: Initiation of Renal Replacement Therapy
timeFrame: Up to 48 hours after CPB
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale School of Medicine
state: Connecticut
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Health Methodist Hospital
state: Indiana
city: West Des Moines
country: United States
facility: Iowa Heart Center
state: Iowa
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Ridgewood
country: United States
facility: Valley Hospital
state: New Jersey
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: New York
country: United States
facility: Northwell Health: Lennox Hill Hospital
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Greenville
country: United States
facility: East Carolina University
state: North Carolina
city: Cincinnati
country: United States
facility: The Christ Hospital Linder Research Center
state: Ohio
city: Columbus
country: United States
facility: Ohio State university
state: Ohio
city: Oklahoma City
country: United States
facility: Integris Baptist Medical Center
state: Oklahoma
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Memphis
country: United States
facility: Baptist Memorial Hospital
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
affiliation: not applicable- Unaffiliated with CytoSorbents
name: Thomas Gleason, MD
role: PRINCIPAL_INVESTIGATOR
References: