Clinical trial NCT06019546: PErfusion QUality ODds
Official title: Perfusion Quality Odds
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiac Disease
Extracorporeal Circulation; Complications
Perfusion; Complications
Acute Kidney Injury
Keywords: acute kidney injury
cardiopulmonary bypass
cardiac surgery
risk score
Lead sponsor: IRCCS Policlinico S. Donato
Sponsor class: OTHER
First posted: 2023-08-31
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients hospitalized in our Institution for a scheduled cardiac surgery with cardiopulmonary bypass

Brief summary: Cardiac surgery-associated acute kidney injury (CSA-AKI) is a frequent complication after cardiac operations with cardiopulmonary bypass (CPB) use. Its frequency varies depending on the severity grade. There are different "static" predictive scores for the CSA-AKI based on the patient and surgery-associated parameters.

Recently, in our Institution was developed a predictive algorithm for CSA-AKI that starts with a static model and then integrated with 7 CPB-associated parameters: HCT, DO2, time of exposure to a critical DO2, systemic pressure, CPB duration time, lactate value, transfusion of red blood cells (RBC), that together build a dynamic perfusion risk (DPR) associated to the CPB. Combining the static and dynamic models produces the Multifactorial Dynamic Perfusion Index (MDPI).

The present study validates MDPI in a new prospective series of patients undergoing cardiac surgery with CPB.

Detailed description: Cardiac surgery-associated acute kidney injury (CSA-AKI) is a frequent complication after cardiac operations with cardiopulmonary bypass (CPB) use. Its frequency varies depending on the severity grade which for the present study follows the AKIN criteria.

There are different predictive scores for the CSA-AKI based on the patient and surgery-associated parameters. These models could be defined as "static".

It's known that a number of CPB-associated parameters could influence CSA-AKI, as well. These include hematocrit (HCT), oxygen delivery (DO2), time of exposure to a critical DO2, and perfusion pressure. These parameters, taken separately, are associated with CSA-AKI development.

Recently, our Institution has developed a predictive algorithm for CSA-AKI that starts with a static model and then integrated with 7 CPB-associated parameters: HCT, DO2, time of exposure to a critical DO2, systemic pressure, CPB duration time, lactate value, transfusion of red blood cells (RBC), that together build a dynamic perfusion risk (DPR) associated to the CPB. Combining the static and dynamic models produces the Multifactorial Dynamic Perfusion Index (MDPI).

MDPI has higher discrimination power when compared to the static scores, in the original series and in the internal validation with the Bootstrap technique.

The present study validates MDPI in a new prospective series of patients undergoing cardiac surgery with CPB. An enrollment of 400 patients is anticipated with a stopping rule for efficacy at interim analysis (for primary endpoint) at 50% enrollment (200 patients) if the c-statistics for any stage of CSA-AKI reaches at least 0.75. Futility is defined as an AUC of 0.6 or lower.

Eligibility 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

Primary outcomes:
measure: Number of patients with postoperative acute kidney injury
timeFrame: First 48 postoperative hours
Secondary outcomes:
measure: Number of patients with postoperative respiratory insufficiency
timeFrame: First 48 postoperative hours
measure: Number of patients with postoperative low cardiac output
timeFrame: First 48 postoperative hours
measure: Number of patients experiencing postoperative major morbidity
timeFrame: First 48 postoperative hours
measure: Number of patients who needed prolonged ICU stay
timeFrame: First 4 postoperative days
measure: Number of deceased patients
timeFrame: 30 days after surgery
Other outcomes:
Locations:
city: San Donato Milanese
country: Italy
facility: IRCCS Policlinico San Donato
state: MI
Study officials:
affiliation: IRCCS Policlinico S. Donato
name: Marco Ranucci, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Ranucci M, Romitti F, Isgro G, Cotza M, Brozzi S, Boncilli A, Ditta A. Oxygen delivery during cardiopulmonary bypass and acute renal failure after coronary operations. Ann Thorac Surg. 2005 Dec;80(6):2213-20. doi: 10.1016/j.athoracsur.2005.05.069.
citation: Ranucci M, Johnson I, Willcox T, Baker RA, Boer C, Baumann A, Justison GA, de Somer F, Exton P, Agarwal S, Parke R, Newland RF, Haumann RG, Buchwald D, Weitzel N, Venkateswaran R, Ambrogi F, Pistuddi V. Goal-directed perfusion to reduce acute kidney injury: A randomized trial. J Thorac Cardiovasc Surg. 2018 Nov;156(5):1918-1927.e2. doi: 10.1016/j.jtcvs.2018.04.045. Epub 2018 Apr 18.
citation: Rasmussen SR, Kandler K, Nielsen RV, Cornelius Jakobsen P, Knudsen NN, Ranucci M, Christian Nilsson J, Ravn HB. Duration of critically low oxygen delivery is associated with acute kidney injury after cardiac surgery. Acta Anaesthesiol Scand. 2019 Nov;63(10):1290-1297. doi: 10.1111/aas.13457. Epub 2019 Sep 10.
citation: de la Hoz MA, Rangasamy V, Bastos AB, Xu X, Novack V, Saugel B, Subramaniam B. Intraoperative Hypotension and Acute Kidney Injury, Stroke, and Mortality during and outside Cardiopulmonary Bypass: A Retrospective Observational Cohort Study. Anesthesiology. 2022 Jun 1;136(6):927-939. doi: 10.1097/ALN.0000000000004175.
citation: Ranucci M, Di Dedda U, Cotza M, Zamalloa Moreano K. The multifactorial dynamic perfusion index: A predictive tool of cardiac surgery associated acute kidney injury. Perfusion. 2024 Jan;39(1):201-209. doi: 10.1177/02676591221137033. Epub 2022 Oct 28.