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Search / Trial NCT06786416

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

Launched by IRCCS POLICLINICO S. DONATO · Jan 15, 2025

Trial Information

Current as of July 01, 2025

Recruiting

Keywords

Cardiopulmonary Bypass Acute Kidney Injury Cardiac Surgery

ClinConnect Summary

This clinical trial is investigating a new system called the Multifactorial Dynamic Perfusion Index (MDPI) that aims to predict and prevent acute kidney injury (AKI) after heart surgery. The MDPI uses a combination of seven different measurements taken during a procedure called cardiopulmonary bypass (CPB), which supports patients' heart and lung function during surgery. The goal is to collect data from 800 adults and 200 infants undergoing cardiac surgery. By analyzing these measurements, the researchers hope to identify patients at risk for AKI and other complications, improving care during and after surgery.

To be eligible for this trial, participants must be undergoing cardiac surgery with CPB and be over 18 years old for adults, or under 6 years old and weigh less than 20 kg for infants. Participants will need to give their consent to join the study. If you participate, you can expect to have your vital signs and other health information monitored during your surgery. This study will help researchers understand how to better predict and manage complications like AKI, which can lead to longer hospital stays or other serious health issues.

Gender

ALL

Eligibility 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

About Irccs Policlinico S. Donato

IRCCS Policlinico S. Donato is a leading Italian research hospital and clinical trial sponsor dedicated to advancing medical science through innovative research and patient care. As an IRCCS (Istituto di Ricovero e Cura a Carattere Scientifico), it is recognized for its commitment to high-quality clinical research and the integration of scientific investigation with clinical practice. The institution specializes in various medical fields, including cardiology, oncology, and neurology, and collaborates with universities and research organizations to facilitate cutting-edge studies. With a focus on improving patient outcomes and contributing to public health, IRCCS Policlinico S. Donato plays a pivotal role in the development of new therapies and treatment protocols.

Locations

San Donato Milanese, Milano, Italy

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported