Renal InsufficiencyBIPASS-AKINCT05990660
Renal Assist Device (RAD) for Patients With Renal Insufficiency Undergoing Cardiac Surgery
A study testing JuxtaFlow System in people with Renal Insufficiency and Acute Kidney Injury, run by 3ive Labs at 3 sites in 2 countries.
Trial summary
The study is a prospective, non-randomized early feasibility study intended to evaluate the safety and performance of the JuxtaFlow System (also known as the JuxtaFlow Renal Assist Device (RAD)) in participants with pre-existing renal insufficiency who are undergoing cardiac surgery. Read more about this study
- Who is it for?
- Ages 22 to 85 years
- Conditions the study is for
- Renal Insufficiency, Acute Kidney Injury
- What is being tested?
- JuxtaFlow System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 28 Sep 2023to 18 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Candidate cardiac surgical patients
- Elective or Urgent on-pump coronary artery bypass grafting (CABG) and/or valvular surgery
- Age 22 to 85 years
- eGFR < 60 mL/min/1.73m2
- Signed informed consent
Who cannot join
- End-stage renal disease (receiving hemodialysis or glomerular filtration rate <15 ml/min/1.73m2)
- Planned off-pump surgery
- Any patients with high-grade proteinuria (i.e., urine protein concentration > 300 mg/dL)
- Pregnancy
- Any secondary condition as determined by the investigator that would place the subject at an increased risk, or preclude the subject's full compliance with the study procedures, including injuries to the urinary organs and/or external genitals
- Current or planned treatment with an investigational drug (IND), device (IDE), or other investigational intervention within 3 months prior to or during participation in this clinical trial
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Serbia2 sites
Institute for Cardiovascular Diseases "Dedinje"
Belgrade
Institute of Cardiovascular Diseases of Vojvodina
Kamenitz
Poland1 site
Polsko-Amerykanskie Kliniki Serca, Centrum Kardiologii
Krakow, Bielsko-Biata, 43-316
About this study
Official title: Bypass Surgery Incorporating a Negative Pressure Renal Assist Device to Resolve AKI
The study is a prospective, non-randomized early feasibility study intended to evaluate the safety and performance of the JuxtaFlow System (also known as the JuxtaFlow Renal Assist Device (RAD)) in participants with pre-existing renal insufficiency who are undergoing cardiac surgery.
Read the detailed description
The BIPASS-AKI study is intended to evaluate participants who are at an increased risk of developing cardiac surgery-associated acute kidney injury (CSA-AKI), and, subsequently, overall poor outcomes. Patients to be considered for participation include those undergoing elective or urgent in-house on-pump cardiac surgery (to include coronary artery bypass graft, valvular surgery, or combination) and have pre-existing renal insufficiency as defined by a pre-operative eGFR between 15-60 mL/min. Participants meeting inclusion and exclusion criteria will be enrolled into a treatment arm (single-arm study) following the completion of informed consent. Participants will receive implantation of the JuxtaFlow Catheters following completion of the their cardiac surgery while remaining under anesthesia. Treatment with the JuxtaFlow System will be initiated upon the participant's arrival into the intensive care unit and continue for up to 24 hours post-operatively. Preoperative, intra-operative, and post-operative data will be collected on participants to include 15- and 30-day follow-up periods.
- Conditions
- Renal Insufficiency, Acute Kidney Injury
- Being tested
- JuxtaFlow System
- Keywords
- Cardiac Surgery Associated Acute Kidney Injury (CSA-AKI), Renal Compromise, Kidney Disease, Cardiopulmonary Bypass, Renal Assist Device (RAD), Cardiac Surgery
- Medical subject headings
- Renal Insufficiency, Acute Kidney Injury, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JuxtaFlow SystemDevice
Mild, controlled negative pressure introduced into the renal pelvis via JuxtaFlow catheters
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Not described Receives: Device: JuxtaFlow System |
What is being measured
The primary outcome is the main question the study is designed to answer.
[Safety] Adverse Events Characterization
The characterization of all type, frequency, severity, and device-relatedness of the adverse events (AEs) associated with the placement, use, and removal of the JuxtaFlow System for the treatment of renal insufficiency in cardiac surgery patients.
Measured: 30 days
[Efficacy] Creatinine Clearance
The change in measured creatinine clearance occurring over the treatment period of 24 hours or less.
Measured: 24 hours
[Efficacy] Urine Sodium Excretion
The change in urine sodium excretion occurring over the treatment period of 24 hours or less.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start28 Sep 2023
- Primary completion28 Dec 2023
- Study completion18 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- BIPASS-AKI is a single-arm, unblinded interventional study designed to assess the safety of the JuxtaFlow System.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- 3ive Labs
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- SCIRENT
- Responsible party
- Sponsor
- Investigators
- Slobodan Micovic, MD, Principal investigator, Institute for Cardiovascular Diseases DedinjeMilovan Petrovic, MD, Principal investigator, Institute of Cardiovascular Diseases of Vojvodina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05990660
- Sponsor's protocol ID
- RAD1117-01
- Acronym
- BIPASS-AKI
- Status last verified
- Jan 2024
- First submitted
- 7 Aug 2023
- Last updated
- 23 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Rodriguez E, Petrovic M, Milewski K, Micovic S, Preveden A, Sanetra K, Kosevic D, Sladen RN. Feasibility Study of Renal Negative Pressure Treatment After Cardiac Surgery With Cardiopulmonary Bypass. Ann Thorac Surg Short Rep. 2026 Feb 26;4(3):1047-1052. doi: 10.1016/j.atssr.2026.01.017. eCollection 2026 Sep.
PubMed 42719646
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bypass Surgery Incorporating a Negative Pressure Renal Assist Device to Resolve AKI
- ClinicalTrials.gov ID
- NCT05990660
- Acronym / sponsor ID
- BIPASS-AKI / RAD1117-01
- Conditions
- Renal Insufficiency, Acute Kidney Injury
- Keywords
- Cardiac Surgery Associated Acute Kidney Injury (CSA-AKI), Renal Compromise, Kidney Disease, Cardiopulmonary Bypass, Renal Assist Device (RAD), Cardiac Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- 3ive LabsIndustry (pharma, biotech, devices)
- Collaborators
- SCIRENT
- Study start
- 28 Sep 2023 (actual)
- Primary completion
- 28 Dec 2023 (actual)
- Study completion
- 18 Jan 2024 (actual)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is a prospective, non-randomized early feasibility study intended to evaluate the safety and performance of the JuxtaFlow System (also known as the JuxtaFlow Renal Assist Device (RAD)) in participants with pre-existing renal insufficiency who are undergoing cardiac surgery.
Detailed description
The BIPASS-AKI study is intended to evaluate participants who are at an increased risk of developing cardiac surgery-associated acute kidney injury (CSA-AKI), and, subsequently, overall poor outcomes. Patients to be considered for participation include those undergoing elective or urgent in-house on-pump cardiac surgery (to include coronary artery bypass graft, valvular surgery, or combination) and have pre-existing renal insufficiency as defined by a pre-operative eGFR between 15-60 mL/min. Participants meeting inclusion and exclusion criteria will be enrolled into a treatment arm (single-arm study) following the completion of informed consent. Participants will receive implantation of the JuxtaFlow Catheters following completion of the their cardiac surgery while remaining under anesthesia. Treatment with the JuxtaFlow System will be initiated upon the participant's arrival into the intensive care unit and continue for up to 24 hours post-operatively. Preoperative, intra-operative, and post-operative data will be collected on participants to include 15- and 30-day follow-up periods.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- BIPASS-AKI is a single-arm, unblinded interventional study designed to assess the safety of the JuxtaFlow System.
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: JuxtaFlow System |
Who may qualify
- Ages
- 22 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Candidate cardiac surgical patients
- Elective or Urgent on-pump coronary artery bypass grafting (CABG) and/or valvular surgery
- Age 22 to 85 years
- eGFR < 60 mL/min/1.73m2
- Signed informed consent
Key exclusion criteria (6 listed)
- End-stage renal disease (receiving hemodialysis or glomerular filtration rate <15 ml/min/1.73m2)
- Planned off-pump surgery
- Any patients with high-grade proteinuria (i.e., urine protein concentration > 300 mg/dL)
- Pregnancy
- Any secondary condition as determined by the investigator that would place the subject at an increased risk, or preclude the subject's full compliance with the study procedures, including injuries to the urinary organs and/or external genitals
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JuxtaFlow SystemMild, controlled negative pressure introduced into the renal pelvis via JuxtaFlow catheters | Device | Treatment |
Primary outcome
[Safety] Adverse Events Characterization
Time frame: 30 days
The characterization of all type, frequency, severity, and device-relatedness of the adverse events (AEs) associated with the placement, use, and removal of the JuxtaFlow System for the treatment of renal insufficiency in cardiac surgery patients.
[Efficacy] Creatinine Clearance
Time frame: 24 hours
The change in measured creatinine clearance occurring over the treatment period of 24 hours or less.
[Efficacy] Urine Sodium Excretion
Time frame: 24 hours
The change in urine sodium excretion occurring over the treatment period of 24 hours or less.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
- Derived from this study: PubMed 42719646Rodriguez E, Petrovic M, Milewski K, Micovic S, Preveden A, Sanetra K, Kosevic D, Sladen RN. Feasibility Study of Renal Negative Pressure Treatment After Cardiac Surgery With Cardiopulmonary Bypass. Ann Thorac Surg Short Rep. 2026 Feb 26;4(3):1047-1052. doi: 10.1016/j.atssr.2026.01.017. eCollection 2026 Sep.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Slobodan Micovic, MD principal investigator
Institute for Cardiovascular Diseases Dedinje
Milovan Petrovic, MD principal investigator
Institute of Cardiovascular Diseases of Vojvodina
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing JuxtaFlow System in people with Renal Insufficiency and Acute Kidney Injury, run by 3ive Labs at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Serbia, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
[Safety] Adverse Events Characterization (time frame: 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05990660, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2024.