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

NCT06786416 | Recruiting

• 2 other identifiers: PEQUOD 2/PNRR-POC-2023-1237702PNRR-POC-2023-1237702
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

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 postoperative AKI defined according to the K-DIGO classification. Workpackage 2 is dedicated to infants, with the purpose of developing an MDPI dedicated to low-weight infants (I-MDPI). This will be develop in Unit 1 that performs congenital heart surgery. The same variables of the MDPI will be collected, plus additional variables specific for infants (blood to prime the oxygenator, plasma for the same purpose; venous oxygen saturation, and others). The variables being independently associated with AKI will enter a logistic regression equation that will be the basis for the I-MDPI. Workpackage 3 considers that AKI is associated with a prolonged mechanical ventilation time, prolonged stay in the intensive care unit and in the hospital; and mortality. Therefore, the MDPI may be predictive of other postoperative complications, apart from AKI, and even of mortality. Some of the factors included in the MDPI may directly (low hematocrit) or indirectly (prolonged CPB duration, excessive hemodilution, low mean arterial pressure) affect the hemostatic system and/or trigger packed red cells transfusions. Additionally, CPB itself is a determinant of a coagulophatic state with associated postoperative bleeding which, in turns, increases the mortality. The specific aim 3 is to confirm the hypothesis that the MDPI may be predictive of one or more of this non-AKI postoperative complications and of 30-days mortality. In the same series of work package and aim 1, these complications will be collected and the MDPI tested for predictive ability of each one of these complications and 30-days mortality. At present, the MDPI can only be calculated off-line, and this greatly limits its applicability. The last step of the aim 3 is based on the involvement of software experts and partnership with companies interested in including the MDPI into their existing monitors; as such, the MDPI patent would be given under licence of the existing patent owned by the IRCCS Policlinico San Donato.

Conditions

Cardiac Diseases; Cardio-pulmonary Bypass; Acute Kidney Injury; Adult Cardiac Surgery; Infants Cardiac Surgery; Extracorporeal Circulation; Complications; Perfusion; Complications

Keywords

cardiopulmonary bypass; acute kidney injury; cardiac surgery

Outcome Measures

Primary Outcomes (1)

• Number of patients with postoperative acute kidney injury

  Occurence of any stage acute kidney injury as defined by the AKIN criteria for adults and KDIGO criteria for infants

  First 48 postoperative hours

Secondary Outcomes (4)

• Number of patients with postoperative low cardiac output

  First 48 postoperative hours

• Number of patients experiencing postoperative major morbidity

  First 48 postoperative hours

• Number of patients who needed prolonged ICU stay

  First 4 postoperative days

• Number of deceased patients

  30 days after surgery

Study Arms (1)

PEQUOD

Patients undergoing cardiac surgery with cardiopulmonary bypass whose parameters of interest will be registered during cardiopulmonary bypass by the Livanova BE-CAPTA monitor.

Other: PEQUOD

Interventions

PEQUOD OTHER

During cardiopulmonary bypass registration of the parameters of interest by the Livanova BE-CAPTA monitor. After surgery, registration of creatinine values up to 48 postoperative hours.

PEQUOD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients hospitalized in our Institution for a scheduled cardiac surgery with cardiopulmonary bypass

You may qualify if:

• 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

You may not qualify if:

• chronic renal failure on dyalisis for WP1 and WP3
• emergency surgery for all WP
• refusal to partecipate

Sponsors & Collaborators

• IRCCS Policlinico S. Donato: lead

Study Sites (1)

IRCCS Policlinico San Donato

San Donato Milanese, Milano, 20097, Italy

RECRUITING

Related Publications (16)

• Brown JK, Shaw AD, Mythen MG, Guzzi L, Reddy VS, Crisafi C, Engelman DT; PeriOperative Quality Initiative and the Enhanced Recovery After Surgery Cardiac Workgroup. Adult Cardiac Surgery-Associated Acute Kidney Injury: Joint Consensus Report. J Cardiothorac Vasc Anesth. 2023 Sep;37(9):1579-1590. doi: 10.1053/j.jvca.2023.05.032. Epub 2023 May 23.

  PMID: 37355415 BACKGROUND

• Karkouti K, Wijeysundera DN, Yau TM, Beattie WS, Abdelnaem E, McCluskey SA, Ghannam M, Yeo E, Djaiani G, Karski J. The independent association of massive blood loss with mortality in cardiac surgery. Transfusion. 2004 Oct;44(10):1453-62. doi: 10.1111/j.1537-2995.2004.04144.x.

  PMID: 15383018 BACKGROUND

• Bartoszko J, Karkouti K. Managing the coagulopathy associated with cardiopulmonary bypass. J Thromb Haemost. 2021 Mar;19(3):617-632. doi: 10.1111/jth.15195. Epub 2020 Dec 17.

  PMID: 33251719 BACKGROUND

• Sanaiha Y, Hadaya J, Verma A, Shemin RJ, Madani M, Young N, Deuse T, Sun J, Benharash P; University of California Cardiac Surgery Consortium. Morbidity and Mortality Associated With Blood Transfusions in Elective Adult Cardiac Surgery. J Cardiothorac Vasc Anesth. 2023 Sep;37(9):1591-1598. doi: 10.1053/j.jvca.2022.11.012. Epub 2022 Nov 17.

  PMID: 36462976 BACKGROUND

• Lee JH, Jung JY, Park SW, Song IK, Kim EH, Kim HS, Kim JT. Risk factors of acute kidney injury in children after cardiac surgery. Acta Anaesthesiol Scand. 2018 Nov;62(10):1374-1382. doi: 10.1111/aas.13210. Epub 2018 Jul 11.

  PMID: 29992550 BACKGROUND

• Zhang Y, Wang B, Zhou XJ, Guo LJ, Zhou RH. Nadir Oxygen Delivery During Pediatric Bypass as a Predictor of Acute Kidney Injury. Ann Thorac Surg. 2022 Feb;113(2):647-653. doi: 10.1016/j.athoracsur.2021.01.026. Epub 2021 Jan 29.

  PMID: 33524358 BACKGROUND

• Puzanov A, Tkachuk V, Maksymenko A. Acute kidney injury after arterial switch operation: incidence, risk factors, clinical impact - a retrospective single-center study. Ren Fail. 2023 Dec;45(1):2167661. doi: 10.1080/0886022X.2023.2167661.

  PMID: 36692196 BACKGROUND

• Levey AS, Levin A, Kellum JA. Definition and classification of kidney diseases. Am J Kidney Dis. 2013 May;61(5):686-8. doi: 10.1053/j.ajkd.2013.03.003. No abstract available.

  PMID: 23582249 BACKGROUND

• 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.

  PMID: 36305847 BACKGROUND

• 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.

  PMID: 31436307 BACKGROUND

• 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.

  PMID: 16305874 BACKGROUND

• Fang WC, Helm RE, Krieger KH, Rosengart TK, DuBois WJ, Sason C, Lesser ML, Isom OW, Gold JP. Impact of minimum hematocrit during cardiopulmonary bypass on mortality in patients undergoing coronary artery surgery. Circulation. 1997 Nov 4;96(9 Suppl):II-194-9.

  PMID: 9386097 BACKGROUND

• Ranucci M, Pavesi M, Mazza E, Bertucci C, Frigiola A, Menicanti L, Ditta A, Boncilli A, Conti D. Risk factors for renal dysfunction after coronary surgery: the role of cardiopulmonary bypass technique. Perfusion. 1994;9(5):319-26. doi: 10.1177/026765919400900503.

  PMID: 7833539 BACKGROUND

• Thakar CV, Arrigain S, Worley S, Yared JP, Paganini EP. A clinical score to predict acute renal failure after cardiac surgery. J Am Soc Nephrol. 2005 Jan;16(1):162-8. doi: 10.1681/ASN.2004040331. Epub 2004 Nov 24.

  PMID: 15563569 BACKGROUND

• Chertow GM, Levy EM, Hammermeister KE, Grover F, Daley J. Independent association between acute renal failure and mortality following cardiac surgery. Am J Med. 1998 Apr;104(4):343-8. doi: 10.1016/s0002-9343(98)00058-8.

  PMID: 9576407 BACKGROUND

• Pickering JW, James MT, Palmer SC. Acute kidney injury and prognosis after cardiopulmonary bypass: a meta-analysis of cohort studies. Am J Kidney Dis. 2015 Feb;65(2):283-93. doi: 10.1053/j.ajkd.2014.09.008. Epub 2014 Nov 5.

  PMID: 25445101 BACKGROUND

MeSH Terms

Conditions

Heart Diseases; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Marco Ranucci, Medicine and Surgery

CONTACT

0252774754; marco.ranucci@grupposandonato.it

Martina Anguissola, Medical Biotechnologies

CONTACT

0252774754; martina.anguissola@rupposandonato.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist

Study Record Dates

• First Submitted: January 15, 2025
• First Posted: January 22, 2025
• Study Start: September 18, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: January 22, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)