Gentle suction on kidneys during heart surgery may prevent damage
NCT ID NCT07017933
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This trial tests a device called JuxtaFlow that applies mild suction to the kidneys during heart surgery. The goal is to see if it can protect kidney function in people with pre-existing kidney problems. 124 adults undergoing heart surgery with a heart-lung machine will be randomly assigned to receive the device or standard care. The study will measure changes in kidney function and any side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Renal assist device (JuxtaFlow RAD) – a device that uses mild suction on the kidneys during heart surgery
- What this could lead to
- If it works, this device could help prevent kidney damage in people with weak kidneys who need heart surgery, reducing complications and hospital stays.
- What could go wrong
- This is an early-stage trial with only 124 participants, so results may not apply to everyone. The device is new and could have unexpected side effects or simply not work as hoped.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 124 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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22 to 85 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: To be eligible for participation in this study, an individual must meet all the following criteria: 1. A candidate for elective or urgent on-pump coronary artery bypass grafting (CABG) and/or valvular surgery 2. Male or Female age 22 to 85 years 3. Estimated glomerular filtration rate (eGFR) 15 - 60 mL/min/1.73m2 4. Signed and dated informed consent 5. Female patients of childbearing potential must: 1. have negative pregnancy test at the informed consent visit, 2. be using previously initiated approved and effective contraception from the informed consent visit through completion of the study \*The only recommended contraception is condoms. Exclusion Criteria: An individual who meets any of the following criteria will be excluded from participation in this study: 1. Any individual, or their legally authorized representative (LAR), who does not understand the requests and risks of participating in the clinical trial or is unable to give informed consent 2. Pregnancy or lactation 3. Prior cardiac surgery within the last 6 months 4. Hemodynamic instability as determined by the Principal Investigator 5. Immunosuppression 6. Active infections (e.g. HIV, Tbc, and all types of Hepatitis) 7. History of polycystic kidney disease 8. Patients with only one active kidney or one poorly functioning kidney 9. Evidence of current kidney obstruction (e.g., Kidney stones) 10. Evidence of current hydronephrosis 11. Active upper and/or lower urinary tract infections 12. Malignancy; oncological Surgery within 5 years or ongoing antitumoral treatment 13. Ongoing sepsis or endocarditis 14. Patients who have an expected 30-day postoperative mortality greater than 10% as determined by the Principal Investigator 15. 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; or severe BPH 16. Unexplained/unexpected gross hematuria as determined by the Investigator 17. 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 18. Patients who have a current unrepaired ureteral avulsion as determined by the investigator 19. Patients otherwise contraindicated for urological interventions, including ureter guidewire placement via bladder cystoscopy and ureteral catheterization, or otherwise contraindicated for any of the other study procedures
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
6 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Locations
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American Heart of Poland
RECRUITINGBielsko-Biala, 43-316, Poland
Contact Email: •••••@•••••
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Cleveland Clinic Florida
RECRUITINGWeston, Florida, 33331, United States
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Medicover Hospital
RECRUITINGWarsaw, 02-972, Poland
Contact Email: •••••@•••••
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Poznan University of Medical Sciences
ACTIVE_NOT_RECRUITINGPoznan, 60-354, Poland
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University of Cincinnati
RECRUITINGCincinnati, Ohio, 45267, United States
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University of Michigan
RECRUITINGAnn Arbor, Michigan, 48109, United States
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University of North Carolina
RECRUITINGChapel Hill, North Carolina, 27514, United States
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- Can watching kidney oxygen during liver surgery keep kidneys safe?