Actively Recruiting

Age: 18Years +
All Genders
ID06786416

A Monitoring System Based on the Multifactorial Dynamic Perfusion Index to Predict and Prevent Postoperative Acute Kidney Injury After Cardiac Surgery Using Dynamic Hemodynamic and Clinical Data During Cardiopulmonary Bypass

Led by IRCCS Policlinico S. Donato · Updated on 2025-01-22

800

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating a predictive tool called the Multifactorial Dynamic Perfusion Index (MDPI) to estimate the risk of acute kidney injury after cardiac surgery involving cardiopulmonary bypass (CPB). This observational study involves adults and infants undergoing cardiac surgery, aiming to validate the MDPI in adults, develop a version for infants under 20 kg, and explore if the MDPI can predict other complications including mortality. The MDPI combines seven variables measured during CPB, many of which can be modified by the surgical team to potentially improve patient outcomes. The study is divided into three parts: first, validating the MDPI in 800 adult cardiac surgery patients from two centers using existing CPB monitors that collect data such as hematocrit, oxygen delivery, arterial pressure, and transfusions; second, developing a modified MDPI for 200 infants under 20 kg undergoing congenital heart surgery with additional infant-specific variables; and third, investigating whether the MDPI can predict other postoperative issues like low cardiac output, longer ICU stays, bleeding complications, and 30-day mortality. Data collection includes parameters recorded during surgery and postoperative creatinine values. Participants will undergo cardiac surgery with CPB, during which relevant physiological data will be continuously recorded by specialized monitors. After surgery, kidney function and other outcomes will be monitored for up to 48 hours, with extended follow-up for complications and mortality over 30 days. Researchers will analyze how well the MDPI predicts acute kidney injury and other clinical outcomes, aiming to incorporate the MDPI into real-time monitoring devices to guide therapeutic decisions during surgery.

CONDITIONS

Brief 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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients undergoing cardiac surgery with cardiopulmonary bypass
  • Patients older than 18 years for work packages 1 and 3
  • Patients younger than 6 years and weighing less than 20 kg for work package 2
  • Willingness to participate and sign the informed consent
Not Eligible

You will not qualify if you...

  • Chronic renal failure requiring dialysis for work packages 1 and 3
  • Emergency surgery for all work packages
  • Refusal to participate

AI-Screening

AI-Powered Screening

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1
2
3
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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - Duration of the cardiac surgery procedure

Participants undergoing cardiac surgery with cardiopulmonary bypass will have dynamic hemodynamic and clinical data collected during the surgery using a specialized monitoring system.

Monitoring during cardiopulmonary bypass surgery

Postoperative Follow-up

Duration - 30 days after surgery

Participants are observed for clinical outcomes including kidney function and other postoperative complications up to 30 days after surgery.

Visits or assessments during the first 48 postoperative hours and follow-up up to 30 days

Trial Site Locations

Total: 1 location

1

IRCCS Policlinico San Donato

San Donato Milanese, Milano, Italy, 20097

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Research Team

M

Marco Ranucci, Medicine and Surgery

M

Martina Anguissola, Medical Biotechnologies

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

Acute kidney injury after arterial switch operation: incidence, risk factors, clinical impact - a retrospective single-center study.

Anton Puzanov, Vadym Tkachuk, Andriy Maksymenko

https://pubmed.ncbi.nlm.nih.gov/36692196

Duration of critically low oxygen delivery is associated with acute kidney injury after cardiac surgery.

Sebastian R Rasmussen, Kristian Kandler, Rikke V Nielsen...

https://pubmed.ncbi.nlm.nih.gov/31436307