Adult Cardiac Surgery-Associated Acute Kidney Injury: Joint Consensus Report.
Jessica K Brown, Andrew D Shaw, Monty G Mythen...
https://pubmed.ncbi.nlm.nih.gov/37355415Actively Recruiting
Led by IRCCS Policlinico S. Donato · Updated on 2025-01-22
800
Participants Needed
1
Research Sites
13 weeks
Total Duration
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
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
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
Total: 1 location
1
IRCCS Policlinico San Donato
San Donato Milanese, Milano, Italy, 20097
Actively Recruiting
M
Marco Ranucci, Medicine and Surgery
M
Martina Anguissola, Medical Biotechnologies
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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