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Study identifier: NCT06786416 Synced from ClinicalTrials.gov · July 29, 2026
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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

Condition: Cardiac Diseases · Cardio-pulmonary Bypass · Acute Kidney Injury  ·  Sponsor: IRCCS Policlinico S. Donato

PhaseN/A
Planned participants800
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

This project is based on a predictive alghorithm (Multifactorial Dynamic Perfusion Index-MDPI) already published and covered by a patent. The MDPI is based on a dynamic collection of 7 different variables during cardiopulmonary bypass (CPB) and provides a probability index for postoperative acute kidney injury. The study design is a multicenter observational prospective trial developed through 3 work packages, addressing (1) external validation of the MDPI in a series of 800 adult cardiac surgery patients collected in 2 Institutions (2) development of a novel MDPI to be applied in infants \< 20 kg undergoing cardiac surgery (200 patients) and (3) verification of of other possible outcomes that may be predicted by the MDPI. Since many of the predictive variables are modifiable by the perfusionist/anesthesiologist during CPB, it is a tool that allows therapeutic manouvres. Ultimately, the MDPI will be incorporated in a dedicated monitor to provide an on-line "flight control" during CPB. Work package 1 will be performed at Units 1 and 2; the parameters composing the MDPI will be collected using the existing CPB monitors that routinely measure the hematocrit, the oxygen delivery, the time of exposure to a pre-defined critical oxygen delivery, the mean arterial pressure, and the CPB duration. Blood lactates and transfusions will be manually inputed. The MDPI will be calculated off-line and tested for association and predictivity (discrimination and calibration) with respect to pos…

This description comes directly from the study's public registry record.

Talk to the study team

Marco Ranucci, Medicine and Surgery  ·  0252774754  ·  marco.ranucci@grupposandonato.it

Martina Anguissola, Medical Biotechnologies  ·  0252774754  ·  martina.anguissola@rupposandonato.it

Always discuss trial participation with your own doctor first.

Locations (1)

IRCCS Policlinico San DonatoSan Donato Milanese, Milano, ItalyRecruiting

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Source record: clinicaltrials.gov/study/NCT06786416