Clinical trial Recruiting at 1 site Observational Ages 18 and up

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 typeObservational
Ages18 Years and up
SexAll
Enrollment800 (estimated)
SponsorIRCCS Policlinico S. Donato
Academic / other
Locations1 site (San Donato Milanese, Milano)
StatusRecruiting
StartedSeptember 18, 2024
Main results expectedJune 2026
Study endsSeptember 2026
Registry record updatedJanuary 22, 2025
Trial IDNCT06786416 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.