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New device aims to prevent kidney failure after heart surgery

NCT ID NCT06811805

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a device called RenalGuard can prevent acute kidney injury in 300 adults undergoing heart surgery. The device monitors and manages urine output during and after surgery. Half the patients will get RenalGuard, the other half standard care. Researchers will check kidney function for up to 90 days after surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
RenalGuard System (a device that manages urine output during and after surgery)
What this could lead to
If it works, this could give doctors a reliable way to prevent kidney damage after heart surgery, reducing the need for dialysis.
What could go wrong
This is a post-market study with 300 patients, so results may not apply to all surgery types. The device may not reduce kidney injury more than standard care.

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

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

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Male or female and \>18 years of age 2. Patient able to give written consent 3. Scheduled for the following non-emergent cardiac surgery procedure requiring CPB, isolated or in combination: * coronary artery bypass graft (CABG) * aortic valve replacement or repair alone, with or without aortic root repair * mitral, tricuspid, or pulmonic valve replacement or repair * simultaneous replacement of several cardiac valves * CABG with aortic, mitral, tricuspid, or pulmonic valve replacement or repair * Surgery on the aorta: aortic root and/ or ascending aorta * Atrial fibrillation (AF) ablation surgery if combined with other cardiac procedures. * Atrial septal defect (ASD) closure if combined with other cardiac procedures. * Excision of myxoma if combined with other cardiac procedures 4. Have at least one of the following risk factors for CSA-AKI: * CKD-EPI eGFR 20-59 mL/min/1.73 m² * Age ≥ 75 years * Undergoing combined surgery (e.g. CABG + Valve) * Logistic EuroScore of ≥5 or, Euroscore II of ≥4 or Society of Thoracic Surgeons (STS) Score ≥4 * Left ventricular ejection fraction (LVEF) ≤ 35% by invasive or noninvasive diagnostic cardiac imaging performed within 90 days prior to surgery. * Insulin-requiring diabetes * Non-insulin-requiring diabetes with HbA1C ≥ 6.1% in the last 6 months * Preoperative anemia within 4 weeks of surgery Exclusion Criteria: 1. Patient requiring emergency surgery 2. Surgery to be performed without CPB 3. Patient receiving furosemide at a dose\>100 mg/day orally (or the equivalent dose of an alternative loop diuretic) in the last week 4. Patient who cannot be urethrally catheterize for any reason 5. Patients already dialysis dependent 6. Patients with CKD-EPI eGFR \<20 mL/min/1.73 m² 7. Known or suspected AKI (KDIGO criteria) at the time of screening 8. Patients participating in another interventional drug or device study or have received an investigational drug or device treatment within the last 30 days 9. Pregnant patient, self-reported 10. Patients whose planned surgery to be performed under conditions of circulatory arrest or hypothermia with rectal temperature \< 28°Celsius (82.4° Fahrenheit) 11. Patient with suspected or confirmed bacteraemia, endocarditis, or pyelonephritis at hospital admission 12. Patients with pneumonia, aspiration, or bilateral pulmonary infiltrates from an infectious aetiology reported on chest x-ray or CT scan in the last 7 days 13. Patients in cardiogenic shock or hemodynamic instability which require inotropes or vasopressors or other mechanical devices (Impella Heart Pump, IABP) within 24 hours prior to surgery 14. Patients on extracorporeal membrane oxygenation (ECMO) or durable ventricular assist device (VAD) at the time of screening, or planned use within 24h prior to surgery 15. Patients currently treated with chemotherapy or radiation therapy that may have an impact on kidney function. 16. Patient underwent prior solid organ transplantation 17. Patients underwent major surgery within the last 3 months 18. Any condition which, in the judgement of the investigator, might increase the risk to the patient.

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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.

Contacts and locations

Locations

  • Hospital Universitario Ramón y Cajal

    Madrid, Spain

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Spain

  • Jessa Medica Center

    Hasselt, Belgium

  • Rabin Medical Center - Belinson Campus

    Petah Tikva, Israel

  • Rambam Medical Center

    Haifa, Israel

  • Sahlgrenska University Hospital

    Gothenburg, Sweden

  • TUM Klinikum Deutsches Herzzentrum

    Munich, Germany

  • Uniklinikum Munster

    Münster, Germany

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