Monitoring system to predict kidney injury after heart surgery
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
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 |
|---|---|
| Enrollment | 800 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS Policlinico S. Donato Academic / other |
| Locations | 1 site (San Donato Milanese, Milano) |
| Trial ID | NCT06786416 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with chronic renal failure on dialysis or those undergoing emergency surgery may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
San Donato Milanese, Milano
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.