Cardiac DiseasesPEQUOD 2NCT06786416
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
An observational study of Cardiac Diseases and Cardio-pulmonary Bypass, run by IRCCS Policlinico S. Donato at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Diseases, Cardio-pulmonary Bypass, Acute Kidney Injury
- What is being tested?
- PEQUOD
- How many people
- 800 participants
- Where
- 1 siteItaly
- Study dates
- 18 Sep 2024to Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients hospitalized in our Institution for a scheduled cardiac surgery with cardiopulmonary bypass
Who may be able to join
- 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
Who cannot join
- chronic renal failure on dyalisis for WP1 and WP3
- emergency surgery for all WP
- refusal to partecipate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Policlinico San Donato
San Donato Milanese, Milano, 20097
Martina Anguissola, Medical Biotechnologies, 0252774754, martina.anguissola@rupposandonato.it
Marco Ranucci, Medicine and Surgery
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 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.
Read the detailed description
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. 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. Cardiac surgery associated acute kidney injury (CSA-AKI) is one of the most common postoperative complications, associated with an increased mortality risk. Several risk scores for CSA-AKI exist. They are based on preoperative risk factors and severity of the procedure. They define a static risk (SR) based on non-modifiable risk factors. As so, they do not consider intraoperative variables, that include potentially modifiable risk factors (dynamic risk, DR). In a previous study we have developed a new model for prediction of CSA-AKI that is inclusive of the SR and the DR, producing the Multifactorial Dynamic Perfusion Index (MDPI). The MDPI is based on 7 factors collected during cardiopulmonary bypass (CPB): oxygen delivery time spent on a low oxygen delivery, hematocrit, time on CPB, mean arterial pressure, transfusions and lactate values. The MDPI showed a better discrimination (AUC 0.769) than the other existing models, and a good calibration until a risk of 60%. Of notice 5 out of the 7 predictors composing the MDPI are modifiable risk factors and therefore can be considered as a ¿flight control¿, on-line measure of the quality of perfusion, to prompt interventions by the perfusionist and the anesthesiologist. The MDPI is covered by an Italian patent (n. 102022000012893) owned by the IRCCS Policlinico San Donato with Marco Ranucci as inventor. The patent covers the inclusion of the MDPI into a dedicated monitor collecting the variables on CPB and producing the MDPI. The activities are separated into 3 work-packages (WP).
WP 1: The MDPI has been developed in a single Institution. Additionally, its validation was performed on the same development series using a bootstrap technique. To make this algorithm exportable in different Institutions, a different new series of patients is required (internal validation) and a new series collected in an external Institution (external validation). Additionally, it cannot be excluded that additional risk factors may be identified and included in the MDPI algorithm; moreover, there is the hypothesis that other outcome measures of morbidity and even mortality may be predicted by the MDPI. WP 1 includes the operative Units 1 and 2 and is based on the collection of a new series of consecutive adult patients requiring cardiac surgery with CPB. The study protocol has been already submitted to the Ethics Committee (166/int/2022) and Clinical Trial. Gov for the internal validation at the operative unit 1 and includes 400 patients. An additional amount of 400 patients will be collected at the operative unit 2. In this series, the MDPI parameters will be collected and assessed for discrimination and calibration properties in predicting CSA-AKI (defined as AKI of any kind, AKI stage and AKI stage 2 or greater). Appropriate tools will be applied to define discrimination (ROC analysis) and calibration (calibration plot using LOWESS) properties of the MDPI. This WP is essentially a validation of the existing MDPI as patented by IRCCS Policlinico San Donato WP2: The MDPI has been develop in the adult patient population. There is little information available in the literature about the CSA-AKI risk factors in infants and newborns weighing < 20 kgs. However, CSA-AKI in this segment of population is present at a rate that is equal or even higher than in the adults. It can be hypothesized that above 20 kgs, the patient is probably comparable to the adult patient, whereas there is a gap in knowledge in infants and newborns. WP2 is intended to cover this gap in knowledge by addressing a series of 200 patients weighing < 20 kgs and receiving cardiac surgery with CPB for palliation or correction of congenital heart defects, producing an MDPI for infants (I MDPI). This WP will be totally performed at the operative unit 2, that is the largest congenital heart center in Italy. A new patent on the I-MDPI is anticipated.
WP3: This WP is based on the same patient population of WP 1, but has a complementary aim. It is in fact possible that (a) other factors apart from the seven included in the MDPI may be associated with CSA-AKI, therefore deserving to be included in the model (MDPI 2.0) and (b) other outcomes, and namely 30-days mortality may be predicted by the MDPI. Once defined these aims, this WP (that includes the 2 operative units) includes the preliminary steps for the implementation of the MDPI into existing or newly developed monitoring systems for CPB. Dedicated patents are anticipated for MDPI 2.0.
- Conditions
- Cardiac Diseases, Cardio-pulmonary Bypass, Acute Kidney Injury, Adult Cardiac Surgery, Infants Cardiac Surgery, Extracorporeal Circulation; Complications
- Being tested
- PEQUOD
- Keywords
- cardiopulmonary bypass, acute kidney injury, cardiac surgery
- Medical subject headings
- Heart Diseases, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEQUODOther
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.
| Study group | Role | What they receive |
|---|---|---|
| PEQUOD | Patients undergoing cardiac surgery with cardiopulmonary bypass whose parameters of interest will be registered during cardiopulmonary bypass by the Livanova BE-CAPTA monitor. Receives: Other: PEQUOD |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: First 48 postoperative hours
Secondary outcomes (4)
Number of patients with postoperative low cardiac output
Use of inotrope drugs for more than 48 hours and/or mechanical support
Measured: First 48 postoperative hours
Number of patients experiencing postoperative major morbidity
As defined by STS criteria as one or more of the following items: AKI stage 2, stroke, mechanical ventilation duration > 48 hours, sepsis, surgical re-exploration
Measured: First 48 postoperative hours
Number of patients who needed prolonged ICU stay
ICU stay duration > 4 days
Measured: First 4 postoperative days
Number of deceased patients
Dead or alive status
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study start18 Sep 2024
- Primary completionJun 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Cardiac DiseasesStudies of the same condition, open and under way.
- More trials run by IRCCS Policlinico S. DonatoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Policlinico S. Donato
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Ranucci, IRCCS Policlinico S. Donato
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06786416
- Sponsor's protocol ID
- PEQUOD 2/PNRR-POC-2023-1237702
- Other IDs
- PNRR-POC-2023-1237702
- Acronym
- PEQUOD 2
- Status last verified
- Jan 2025
- First submitted
- 15 Jan 2025
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The original dataset supporting the findings of this study will be deposited in the public repository Zenodo after the publication of the work and accessible upon a reasonable request. The requests should be addressed to the Principal Investigator of the study.
Publications
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.
PubMed 37355415Karkouti 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.
PubMed 15383018Bartoszko 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.
PubMed 33251719Sanaiha 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.
PubMed 36462976Lee 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.
PubMed 29992550Zhang 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.
PubMed 33524358Puzanov 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.
PubMed 36692196Levey 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.
PubMed 23582249Ranucci 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.
PubMed 36305847Rasmussen 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.
PubMed 31436307Ranucci 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.
PubMed 16305874Fang 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.
PubMed 9386097Ranucci 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.
PubMed 7833539Thakar 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.
PubMed 15563569Chertow 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.
PubMed 9576407
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06786416
- Acronym / sponsor ID
- PEQUOD 2 / PEQUOD 2/PNRR-POC-2023-1237702
- Conditions
- Cardiac Diseases, Cardio-pulmonary Bypass, Acute Kidney Injury, Adult Cardiac Surgery, Infants Cardiac Surgery, Extracorporeal Circulation; Complications
- Keywords
- cardiopulmonary bypass, acute kidney injury, cardiac surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- IRCCS Policlinico S. DonatoUniversity, hospital or other
- Study start
- 18 Sep 2024 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 22 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. 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. Cardiac surgery associated acute kidney injury (CSA-AKI) is one of the most common postoperative complications, associated with an increased mortality risk. Several risk scores for CSA-AKI exist. They are based on preoperative risk factors and severity of the procedure. They define a static risk (SR) based on non-modifiable risk factors. As so, they do not consider intraoperative variables, that include potentially modifiable risk factors (dynamic risk, DR). In a previous study we have developed a new model for prediction of CSA-AKI that is inclusive of the SR and the DR, producing the Multifactorial Dynamic Perfusion Index (MDPI). The MDPI is based on 7 factors collected during cardiopulmonary bypass (CPB): oxygen delivery time spent on a low oxygen delivery, hematocrit, time on CPB, mean arterial pressure, transfusions and lactate values. The MDPI showed a better discrimination (AUC 0.769) than the other existing models, and a good calibration until a risk of 60%. Of notice 5 out of the 7 predictors composing the MDPI are modifiable risk factors and therefore can be considered as a ¿flight control¿, on-line measure of the quality of perfusion, to prompt interventions by the perfusionist and the anesthesiologist. The MDPI is covered by an Italian patent (n. 102022000012893) owned by the IRCCS Policlinico San Donato with Marco Ranucci as inventor. The patent covers the inclusion of the MDPI into a dedicated monitor collecting the variables on CPB and producing the MDPI. The activities are separated into 3 work-packages (WP).
WP 1: The MDPI has been developed in a single Institution. Additionally, its validation was performed on the same development series using a bootstrap technique. To make this algorithm exportable in different Institutions, a different new series of patients is required (internal validation) and a new series collected in an external Institution (external validation). Additionally, it cannot be excluded that additional risk factors may be identified and included in the MDPI algorithm; moreover, there is the hypothesis that other outcome measures of morbidity and even mortality may be predicted by the MDPI. WP 1 includes the operative Units 1 and 2 and is based on the collection of a new series of consecutive adult patients requiring cardiac surgery with CPB. The study protocol has been already submitted to the Ethics Committee (166/int/2022) and Clinical Trial. Gov for the internal validation at the operative unit 1 and includes 400 patients. An additional amount of 400 patients will be collected at the operative unit 2. In this series, the MDPI parameters will be collected and assessed for discrimination and calibration properties in predicting CSA-AKI (defined as AKI of any kind, AKI stage and AKI stage 2 or greater). Appropriate tools will be applied to define discrimination (ROC analysis) and calibration (calibration plot using LOWESS) properties of the MDPI. This WP is essentially a validation of the existing MDPI as patented by IRCCS Policlinico San Donato WP2: The MDPI has been develop in the adult patient population. There is little information available in the literature about the CSA-AKI risk factors in infants and newborns weighing < 20 kgs. However, CSA-AKI in this segment of population is present at a rate that is equal or even higher than in the adults. It can be hypothesized that above 20 kgs, the patient is probably comparable to the adult patient, whereas there is a gap in knowledge in infants and newborns. WP2 is intended to cover this gap in knowledge by addressing a series of 200 patients weighing < 20 kgs and receiving cardiac surgery with CPB for palliation or correction of congenital heart defects, producing an MDPI for infants (I MDPI). This WP will be totally performed at the operative unit 2, that is the largest congenital heart center in Italy. A new patent on the I-MDPI is anticipated.
WP3: This WP is based on the same patient population of WP 1, but has a complementary aim. It is in fact possible that (a) other factors apart from the seven included in the MDPI may be associated with CSA-AKI, therefore deserving to be included in the model (MDPI 2.0) and (b) other outcomes, and namely 30-days mortality may be predicted by the MDPI. Once defined these aims, this WP (that includes the 2 operative units) includes the preliminary steps for the implementation of the MDPI into existing or newly developed monitoring systems for CPB. Dedicated patents are anticipated for MDPI 2.0.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PEQUOD | – | Other: PEQUODPatients undergoing cardiac surgery with cardiopulmonary bypass whose parameters of interest will be registered during cardiopulmonary bypass by the Livanova BE-CAPTA monitor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized in our Institution for a scheduled cardiac surgery with cardiopulmonary bypass
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- chronic renal failure on dyalisis for WP1 and WP3
- emergency surgery for all WP
- refusal to partecipate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEQUODDuring 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. | Other | PEQUOD |
Primary outcome
Number of patients with postoperative acute kidney injury
Time frame: First 48 postoperative hours
Occurence of any stage acute kidney injury as defined by the AKIN criteria for adults and KDIGO criteria for infants
4 secondary outcomes
Number of patients with postoperative low cardiac output
Time frame: First 48 postoperative hours
Number of patients experiencing postoperative major morbidity
Time frame: First 48 postoperative hours
Number of patients who needed prolonged ICU stay
Time frame: First 4 postoperative days
Number of deceased patients
Time frame: 30 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
- Background: PubMed 37355415Brown 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.
- Background: PubMed 15383018Karkouti 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.
- Background: PubMed 33251719Bartoszko 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.
- Background: PubMed 36462976Sanaiha 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.
- Background: PubMed 29992550Lee 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.
- Background: PubMed 33524358Zhang 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.
- Background: PubMed 36692196Puzanov 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.
- Background: PubMed 23582249Levey 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.
- Background: PubMed 36305847Ranucci 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.
- Background: PubMed 31436307Rasmussen 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.
- Background: PubMed 16305874Ranucci 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.
- Background: PubMed 9386097Fang 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.
- Individual participant dataSharing planned: No. The original dataset supporting the findings of this study will be deposited in the public repository Zenodo after the publication of the work and accessible upon a reasonable request. The requests should be addressed to the Principal Investigator of the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Diseases and Cardio-pulmonary Bypass, run by IRCCS Policlinico S. Donato at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marco Ranucci, Medicine and Surgery (0252774754, marco.ranucci@grupposandonato.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with postoperative acute kidney injury (time frame: First 48 postoperative hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06786416, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2025.