Acute Kidney Injury
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEAortix System
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.
Sponsors
Procyrion Australia Pty Ltd
Procyrion
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Have the following risk factor(s) for AKI prior to surgery: 1. Estimated glomerular filtration rate (eGFR) of ≥ 15 and \< 30 ml/min/1.73m2, OR 2. eGFR ≥ 30 and \< 60 ml/min/1.73m2 and ONE or more of the following: 1. Diabetes (regardless of cause) with metabolic, renal, ophthalmic, neurologic, circulatory, or other complications 2. Documented NYHA class III or IV heart failure within 1 year prior to enrollment 3. Left ventricular ejection fraction \< 35% 4. Hypertension with comorbid heart or kidney disease 5. Persistent Atrial Fibrillation 2. Planned (non-emergency) cardiac surgical procedure including, but not limited to coronary bypass surgery, surgical valve replacement or valve repair 3. Age \>21 years, willing and able to provide written informed consent. \-
Exclusion criteria
1. An eGFR of \<15 ml/min/1.73m2 at enrollment 2. Cardiac surgical procedure that uses femoral artery cannulation for cardiopulmonary bypass 3. Current support with a durable LVAD, intra-aortic balloon pump, extracorporeal membrane oxygenation (ECMO), or percutaneous ventricular assist devices (e.g., Impella or TandemHeart) 4. Patient has known hypo- or hyper-coagulable state such as disseminated intravascular coagulation or heparin induced thrombocytopenia (HIT) 5. Endovascular procedure with ilio-femoral access \>12F within previous 30 days 6. Severe Bleeding Risk (any of the following): 1. Previous intracranial bleed such that the patient cannot safely use anticoagulation per the study requirements 2. Platelet count \<75,000 cells/mm3 3. Uncorrectable bleeding diathesis or coagulopathy (e.g., INR ≥ 2 not due to anticoagulation therapy 7. Current endovascular stent graft in the descending aorta or either ilio-femoral vessels 8. Contraindicated Anatomy: 1. Descending aortic anatomy that would prevent safe placement of the device \[\<18 mm or \>31 mm aorta diameter at deployment location (measured between the superior aspect of the T10 vertebra and superior aspect of the L1 vertebra)\] 2. Ilio-femoral diameter or peripheral vascular anatomy that would preclude safe placement of a 21F (outer diameter) introducer sheath 3. Abnormalities or severe vascular disease that would preclude safe access and device delivery (e.g., aneurysm with thrombus; marked tortuosity; significant narrowing or inadequate size of the abdominal aorta, iliac, or femoral arteries; or severe calcification) 4. Known connective tissue disorder (e.g., Marfan Syndrome) or other aortopathy at risk of vascular injury 9. Known hypersensitivity or contraindication to study required medications (e.g., anticoagulation therapy) or device materials (e.g., history of severe reaction to nickel or nitinol) 10. Positive pregnancy test if of childbearing potential 11. Participation in any other clinical investigation that is likely to confound study results or affect the study \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Serious Adverse Events Related to Aortix | Enrollment to 30 days post-surgery | The number of participants with Serious Adverse Events related to the Aortix implant, retrieval, and therapy. |
| Number of Participants With Baseline AKI Stage Compared to AKI Stage at 72 Hours Post-surgery | Baseline to 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. |
| Number of Participants Requiring Postoperative Use of Renal Replacement Therapy, Ultrafiltration, and/or Dialysis. | Aortix placement to 30 days post- surgery | 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. |
| Effectiveness | If discharged by day 30 post-surgery | Characterize the rate of 30-day post-surgery readmission due to worsening renal function |
Countries
Australia
Participant flow
Recruitment details
Patients were enrolled at 4 investigational sites in Australia between July 17, 2022 and August 7, 2023.
Participants by arm
| Arm | Count |
|---|---|
| Aortix Arm Patients who meet all inclusion and none of the exclusion criteria for the study and agree to receive the Aortix system implant are followed in the Aortix Arm. | 8 |
| Non-Aortix Arm Patients who decline Aortix system implant or fail to meet anatomical requirements for Aortix implant are followed in the non-Aortix arm. | 9 |
| Total | 17 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Study enrollment stopped prior to implant. | 1 | 0 |
| Overall Study | Surgery completed at hospital not participating in the study. | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Total | Aortix Arm | Non-Aortix Arm |
|---|---|---|---|
| Age, Continuous | 68.9 years STANDARD_DEVIATION 8.07 | 66.0 years STANDARD_DEVIATION 8.67 | 71.4 years STANDARD_DEVIATION 6.98 |
| AKI Stage AKI Stage 1 | 2 Participants | 1 Participants | 1 Participants |
| AKI Stage AKI Stage 2 | 0 Participants | 0 Participants | 0 Participants |
| AKI Stage AKI Stage 3 | 2 Participants | 0 Participants | 2 Participants |
| AKI Stage None | 13 Participants | 7 Participants | 6 Participants |
| BMI | 29.1 kg/m^2 STANDARD_DEVIATION 6.71 | 32.2 kg/m^2 STANDARD_DEVIATION 7.04 | 25.4 kg/m^2 STANDARD_DEVIATION 4.05 |
| eGFR | 48.1 ml/min/1.73m^2 STANDARD_DEVIATION 9.58 | 49.9 ml/min/1.73m^2 STANDARD_DEVIATION 8.32 | 46.6 ml/min/1.73m^2 STANDARD_DEVIATION 10.82 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 17 Participants | 8 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Height | 172.7 cm STANDARD_DEVIATION 8.87 | 172.6 cm STANDARD_DEVIATION 8.92 | 172.9 cm STANDARD_DEVIATION 9.37 |
| LVEF | 52.2 percentage of LV ejection fraction STANDARD_DEVIATION 15.21 | 47.0 percentage of LV ejection fraction STANDARD_DEVIATION 16.46 | 56.8 percentage of LV ejection fraction STANDARD_DEVIATION 13.24 |
| NYHA Classification Class I | 5 Participants | 2 Participants | 3 Participants |
| NYHA Classification Class II | 3 Participants | 0 Participants | 3 Participants |
| NYHA Classification Class III | 8 Participants | 5 Participants | 3 Participants |
| NYHA Classification Class IV | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 15 Participants | 7 Participants | 8 Participants |
| Sex: Female, Male Female | 3 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Male | 14 Participants | 7 Participants | 7 Participants |
| Weight | 88.0 kg STANDARD_DEVIATION 20.71 | 101.4 kg STANDARD_DEVIATION 19.74 | 76.0 kg STANDARD_DEVIATION 13.31 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 9 |
| other Total, other adverse events | 6 / 8 | 3 / 9 |
| serious Total, serious adverse events | 8 / 8 | 4 / 9 |
Outcome results
Primary
Effectiveness
Characterize the rate of 30-day post-surgery readmission due to worsening renal function
Time frame: If discharged by day 30 post-surgery
Population: Participants who completed the study are included in this analysis. One patient in the Aortix Arm is excluded from this analysis due to significant change in medical status.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Aortix Arm | Effectiveness | 0 Participants |
| Non-Aortix Arm | Effectiveness | 0 Participants |
Primary
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
Population: All participants who completed the study are included in this analysis. One patient in the Aortix Arm was excluded due to significant change in medical status.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Aortix Arm | Number of Participants Requiring Postoperative Use of Renal Replacement Therapy, Ultrafiltration, and/or Dialysis. | 1 Participants |
| Non-Aortix Arm | Number of Participants Requiring Postoperative Use of Renal Replacement Therapy, Ultrafiltration, and/or Dialysis. | 1 Participants |
Primary
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
Population: All participants who completed follow up in the study. 1 participant in the Aortix arm was excluded from analysis due to significant change in medical status.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Aortix Arm | Number of Participants With Baseline AKI Stage Compared to AKI Stage at 72 Hours Post-surgery | From None to AKI Stage 1 | 4 Participants |
| Aortix Arm | Number of Participants With Baseline AKI Stage Compared to AKI Stage at 72 Hours Post-surgery | From None to AKI Stage 3 | 1 Participants |
| Aortix Arm | Number of Participants With Baseline AKI Stage Compared to AKI Stage at 72 Hours Post-surgery | From AKI Stage 1 to None | 0 Participants |
| Aortix Arm | Number of Participants With Baseline AKI Stage Compared to AKI Stage at 72 Hours Post-surgery | No Change | 1 Participants |
| Aortix Arm | Number of Participants With Baseline AKI Stage Compared to AKI Stage at 72 Hours Post-surgery | Missing Data | 0 Participants |
| Aortix Arm | Number of Participants With Baseline AKI Stage Compared to AKI Stage at 72 Hours Post-surgery | From None to AKI Stage 2 | 1 Participants |
| Non-Aortix Arm | Number of Participants With Baseline AKI Stage Compared to AKI Stage at 72 Hours Post-surgery | Missing Data | 1 Participants |
| Non-Aortix Arm | Number of Participants With Baseline AKI Stage Compared to AKI Stage at 72 Hours Post-surgery | No Change | 7 Participants |
| Non-Aortix Arm | Number of Participants With Baseline AKI Stage Compared to AKI Stage at 72 Hours Post-surgery | From None to AKI Stage 1 | 0 Participants |
| Non-Aortix Arm | Number of Participants With Baseline AKI Stage Compared to AKI Stage at 72 Hours Post-surgery | From None to AKI Stage 2 | 0 Participants |
| Non-Aortix Arm | Number of Participants With Baseline AKI Stage Compared to AKI Stage at 72 Hours Post-surgery | From AKI Stage 1 to None | 1 Participants |
| Non-Aortix Arm | Number of Participants With Baseline AKI Stage Compared to AKI Stage at 72 Hours Post-surgery | From None to AKI Stage 3 | 0 Participants |
Primary
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
Population: All participants that had an attempted or successful Aortix device implant.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Aortix Arm | Number of Participants With Serious Adverse Events Related to Aortix | Bleeding (BARC 3b) | 1 Participants |
| Aortix Arm | Number of Participants With Serious Adverse Events Related to Aortix | Hemolysis, Transient, Major | 1 Participants |
| Aortix Arm | Number of Participants With Serious Adverse Events Related to Aortix | No Serious Related Adverse Events | 6 Participants |