An interventional study of Aortix System in Acute Kidney Injury, sponsored by Procyrion. Terminated at 5 sites in Australia. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2024-11-12.
Sponsored by Procyrion · Not applicable, Interventional, and Prevention
Among 23 studies in Acute Kidney Injury with a site in Australia — 3 open to participants now, 4 under way, none of them phase 3. Acute Kidney Injury · Australia.
Among the 23 studies in Acute Kidney Injury with a site in Australia, this one is the 16th largest by enrollment of the 18 interventional ones, is the only one that started in 2022, is one of 4 with no phase, and was the 16th registered.
1,691 studies on the registry are indexed under Acute Kidney Injury; 395 are open to participants now.
This study's enrollment of 20 is below the median of 100 across 817 interventional studies indexed under Acute Kidney Injury.
Browse Acute Kidney Injury studies →3 of the 23 studies in Acute Kidney Injury with a site in Australia are open now, in 12 countries. Each count lists the studies.
Of the 230 Acute Kidney Injury studies recruiting now, 161 (70%) set no upper age limit and 36 (16%) stop at 75 or younger; 22 take children under 18; 25 take healthy volunteers.
This study: 21 Years and older · all sexes · no healthy volunteers.
The full table on the hub →23 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 1 started in 2022.
Median enrollment 208 across the 18 interventional studies, 2,000 across the 5 observational. Of the 18 that completed or were terminated, 4 (22%) have results posted.
5 of 23 have an industry lead sponsor. The 10 most frequent:
Procyrion is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Procyrion has 1 study filed under Acute Kidney Injury — fewer than ten, so there is no comparison to draw.
3 of the studies in Acute Kidney Injury with a site in Australia that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07579390Helsinki University Central HospitalEffects of Sedation, TEmperature and Pressure After Cardiac Arrest and REsuscitation on Major Adverse Kidney Events (STEPCARE-MAKE) | 2026-12 |
| NCT06823115Indiana UniversityAssessment of Worldwide Acute Kidney Injury Epidemiology in Neonates 2.0 | 2027-01 |
| NCT07438262Australian and New Zealand Intensive Care Research CentreThe AminoECMO Pilot Trial | 2027-08-30 |
Among the 23 studies in Acute Kidney Injury with a site in Australia, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Have the following risk factor(s) for AKI prior to surgery:
eGFR ≥ 30 and \< 60 ml/min/1.73m2 and ONE or more of the following:
-
Exclusion Criteria:
Severe Bleeding Risk (any of the following):
Anatomy:
Participation in any other clinical investigation that is likely to confound study results or affect the study
-
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subject receives the Aortix device.
Device: Aortix System
Control Arm consists of subjects who choose not to receive the Aortix device or who do not meet the anatomical requirements to receive the Aortix device.
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.
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
Patients were enrolled at 4 investigational sites in Australia between July 17, 2022 and August 7, 2023.
| Milestone | Aortix Arm | Non-Aortix Arm |
|---|---|---|
| Started | 11 | 9 |
| Completed | 8 | 9 |
| Not completed | 3 | 0 |
| Withdrew: Surgery completed at hospital not participating in the study. | 1 | 0 |
| Withdrew: Study enrollment stopped prior to implant. | 1 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 |
The number of participants with Serious Adverse Events related to the Aortix implant, retrieval, and therapy.
| Participants | Aortix Arm |
|---|---|
| Bleeding (BARC 3b) | 1 |
| Hemolysis, Transient, Major | 1 |
| No Serious Related Adverse Events | 6 |
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.
| Participants | Aortix Arm | Non-Aortix Arm |
|---|---|---|
| No Change | 1 | 7 |
| From None to AKI Stage 1 | 4 | 0 |
| From None to AKI Stage 2 | 1 | 0 |
| From None to AKI Stage 3 | 1 | 0 |
| From AKI Stage 1 to None | 0 | 1 |
| Missing Data | 0 | 1 |
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.
| Participants | Aortix Arm | Non-Aortix Arm |
|---|---|---|
| Number of Participants Requiring Postoperative Use of Renal Replacement Therapy, Ultrafiltration, and/or Dialysis. | 1 | 1 |
Characterize the rate of 30-day post-surgery readmission due to worsening renal function
| Participants | Aortix Arm | Non-Aortix Arm |
|---|---|---|
| Effectiveness | 0 | 0 |
Collected over Adverse Events were collected from enrollment to 30-Days post surgery.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Aortix Arm | 0/8 (0%) | 8/8 (100%) | 6/8 (75%) |
| Non-Aortix Arm | 0/9 (0%) | 4/9 (44.4%) | 3/9 (33.3%) |
| Event | Aortix Arm | Non-Aortix Arm |
|---|---|---|
| BleedingVascular disorders | 4/8 | 2/9 |
| Renal InjuryRenal and urinary disorders | 2/8 | 1/9 |
| OtherGeneral disorders | 2/8 | 1/9 |
| Hemolysis, Transient, MajorBlood and lymphatic system disorders | 1/8 | 0/9 |
| Cardiogenic ShockCardiac disorders | 1/8 | 1/9 |
| Psychiatric EpisodePsychiatric disorders | 1/8 | 0/9 |
| AnemiaBlood and lymphatic system disorders | 1/8 | 0/9 |
| HypotensionCardiac disorders | 1/8 | 0/9 |
| Pericardial EffusionCardiac disorders | 0/8 | 1/9 |
| Vascular InjuryVascular disorders | 0/8 | 1/9 |
| Event | Aortix Arm | Non-Aortix Arm |
|---|---|---|
| Renal InjuryRenal and urinary disorders | 3/8 | 1/9 |
| Bleeding EventVascular disorders | 1/8 | 0/9 |
| Pleural EffusionRespiratory, thoracic and mediastinal disorders | 1/8 | 1/9 |
| OtherGeneral disorders | 1/8 | 0/9 |
| ArrhythmiaCardiac disorders | 0/8 | 1/9 |
| GI MiscellaneousGastrointestinal disorders | 0/8 | 1/9 |
All participants that completed the study follow-up.
| Age, Continuous(years) | Aortix Arm | Non-Aortix Arm | Total |
|---|---|---|---|
| Mean | 66.0 ± 8.67 | 71.4 ± 6.98 | 68.9 ± 8.07 |
| Sex: Female, Male(Participants) | Aortix Arm | Non-Aortix Arm | Total |
|---|---|---|---|
| Female | 1 | 2 | 3 |
| Male | 7 | 7 | 14 |
| Ethnicity (NIH/OMB)(Participants) | Aortix Arm | Non-Aortix Arm | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 8 | 9 | 17 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Aortix Arm | Non-Aortix Arm | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 7 | 8 | 15 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 1 | 2 |
| AKI Stage(Participants) | Aortix Arm | Non-Aortix Arm | Total |
|---|---|---|---|
| AKI Stage 1 | 1 | 1 | 2 |
| AKI Stage 2 | 0 | 0 | 0 |
| AKI Stage 3 | 0 | 2 | 2 |
| None | 7 | 6 | 13 |
| eGFR(ml/min/1.73m^2) | Aortix Arm | Non-Aortix Arm | Total |
|---|---|---|---|
| Mean | 49.9 ± 8.32 | 46.6 ± 10.82 | 48.1 ± 9.58 |
| NYHA Classification(Participants) | Aortix Arm | Non-Aortix Arm | Total |
|---|---|---|---|
| Class I | 2 | 3 | 5 |
| Class II | 0 | 3 | 3 |
| Class III | 5 | 3 | 8 |
| Class IV | 1 | 0 | 1 |
| LVEF(percentage of LV ejection fraction) | Aortix Arm | Non-Aortix Arm | Total |
|---|---|---|---|
| Mean | 47.0 ± 16.46 | 56.8 ± 13.24 | 52.2 ± 15.21 |
3 further baseline measures are reported on the registry.
Plan to share: No
Ran from Jul 2022 to primary completion in Aug 2023, 13 months.
Results were first posted in Nov 2024, 1 year 2 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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