Monitoring system to predict kidney injury after heart surgery
Official title: A Monitoring System Based on the Multifactorial Dynamic Perfusion Index to Predict and Prevent the Onset of Postoperative Acute Kidney Injury After Cardiac Surgery, Based on a Dynamic Collection of Hemodynamic and Clinical Parameters During Cardiopulmonary Bypass
Run by IRCCS Policlinico S. Donato · NCT06786416 · Data updated 2026-11-12
This study is testing a new monitoring system to see if it can help predict and prevent kidney injury in adults and infants undergoing heart surgery.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 800 (estimated) |
| Sponsor | IRCCS Policlinico S. Donato Academic / other |
| Locations | 1 site (San Donato Milanese, Milano) |
| Status | Recruiting |
| Started | September 18, 2024 |
| Main results expected | June 2026 |
| Study ends | September 2026 |
| Registry record updated | January 22, 2025 |
| Trial ID | NCT06786416 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults over 18 and infants under 6 years old weighing less than 20 kg who are scheduled for cardiac surgery with cardiopulmonary bypass.
✕Probably not a fit
Patients with chronic renal failure on dialysis or those undergoing emergency surgery may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to validate a predictive algorithm called the Multifactorial Dynamic Perfusion Index (MDPI) that assesses the risk of postoperative acute kidney injury in patients undergoing cardiac surgery with cardiopulmonary bypass. The study will involve 800 adult patients and 200 infants, collecting dynamic hemodynamic and clinical parameters during surgery to enhance the predictive accuracy of the MDPI. The goal is to develop a monitoring tool that allows for real-time adjustments during surgery to potentially prevent kidney injury. The study is structured into three work packages focusing on validation, development for infants, and exploration of additional outcomes.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of acute kidney injury in patients undergoing cardiac surgery, improving postoperative outcomes.
How similar studies have gone: While there are existing risk scores for acute kidney injury, this approach utilizing dynamic intraoperative variables is relatively novel and has not been extensively tested in similar studies.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * patients undergoing cardiac surgery with cardiopulmonary bypass * patients \>18 years for WP1 and WP3; patients \<6 years and weight \<20 kg for WP2 * willingness to participate and sign the informed consent Exclusion Criteria: * chronic renal failure on dyalisis for WP1 and WP3 * emergency surgery for all WP * refusal to partecipate
Where it's running
-
IRCCS Policlinico San Donato
San Donato Milanese, Milano, Italy Recruiting
Study contacts
- Study coordinator: Marco Ranucci, Medicine and Surgery
- Email: marco.ranucci@grupposandonato.it
- Phone: 0252774754
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.