Validation of a new risk index for kidney injury after heart surgery
Perfusion Quality Odds
This study is testing a new tool to see if it can better predict the risk of kidney injury in patients undergoing heart surgery with a heart-lung machine.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS Policlinico S. Donato Academic / other |
| Locations | 1 site (San Donato Milanese, MI) |
| Trial ID | NCT06019546 on ClinicalTrials.gov |
What this trial studies
This study aims to validate a newly developed predictive algorithm called the Multifactorial Dynamic Perfusion Index (MDPI) for assessing the risk of cardiac surgery-associated acute kidney injury (CSA-AKI) in patients undergoing cardiac surgery with cardiopulmonary bypass (CPB). The MDPI combines static patient and surgery-related parameters with dynamic CPB-associated factors to improve risk prediction. The study will enroll approximately 400 patients and will assess the effectiveness of the MDPI in a prospective setting, comparing it to existing static predictive scores.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are scheduled for cardiac surgery involving cardiopulmonary bypass.
Not a fit: Patients requiring preoperative dialysis will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved risk assessment and management strategies for preventing acute kidney injury in patients undergoing cardiac surgery.
How similar studies have performed: Other studies have shown promise in using dynamic models for predicting complications in cardiac surgery, but the MDPI approach is novel in its specific integration of CPB-associated parameters.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * patients undergoing cardiac surgery with cardiopulmonary bypass * age of 18 years and higher * willingness to participate and sign the informed consent Exclusion Criteria: - patients requiring preoperative dialysis
Where this trial is running
San Donato Milanese, MI
- IRCCS Policlinico San Donato — San Donato Milanese, Mi, Italy (Recruiting)
Study contacts
- Principal investigator: Marco Ranucci, MD — IRCCS Policlinico S. Donato
- Study coordinator: Marco Ranucci, MD
- 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.