The study is a prospective, non-randomized feasibility study to evaluate the safety and performance of providing support with the Aortix System to patients at heightened risk of acute kidney injury (AKI) undergoing cardiovascular surgery.
The study is a prospective, non-randomized feasibility study to evaluate the safety and performance of providing support with the Aortix System to patients at heightened risk of acute kidney injury (AKI) undergoing cardiovascular surgery. Patients who decline Aortix system implant or fail to meet anatomical requirements for Aortix implant will be followed in the non-Aortix arm. Both arms will have the same visit schedule and data collection requirements with the exception of data pertaining to the Aortix system. Data will be reported for both groups.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
20
Aortix is indicated as a partial circulatory support device to increase renal perfusion and reduce the incidence of acute kidney injury (AKI) in patients undergoing cardiac surgery who are at heightened risk of developing AKI.
Royal Adelaide Hospital
Adelaide, Australia
Prince Charles Hospital
Brisbane, Australia
Princess Alexandra Hospital
Brisbane, Australia
Monash Health
Melbourne, Australia
Macquarie University
Number of Participants With Serious Adverse Events Related to Aortix
The number of participants with Serious Adverse Events related to the Aortix implant, retrieval, and therapy.
Time frame: Enrollment to 30 days post-surgery
Number of Participants With Baseline AKI Stage Compared to AKI Stage at 72 Hours Post-surgery
The intention is to characterize the change in severity of acute kidney injury observed at 72 hours post-surgery using the KDIGO AKI staging criteria. AKI Stage as defined by the Kidney Disease Improving Global Outcomes (KDIGO) clinical practice guidelines defines the level of acute kidney injury with Stage 1 being the lowest level of kidney injury and Stage 3 being the most severe. None refers to no acute kidney injury.
Time frame: Baseline to 72 hours post-surgery
Number of Participants Requiring Postoperative Use of Renal Replacement Therapy, Ultrafiltration, and/or Dialysis.
Renal replacement therapy (RRT), ultrafiltration, and dialysis are three treatment options for subjects with severe acute kidney injury and serve as a measure of the degree of acute kidney injury experienced by each group. Any subject receiving any of these therapies prior to 30 days post surgery are counted in this analysis.
Time frame: Aortix placement to 30 days post- surgery
Effectiveness
Characterize the rate of 30-day post-surgery readmission due to worsening renal function
Time frame: If discharged by day 30 post-surgery
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Sydney, Australia