- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05537168
Bayesian Networks in Pediatric Cardiac Surgery
Use of Deep Neural Networks and Bayesian Analysis to Identify Risk Factors for Poor Outcome After Pediatric Cardiac Surgery
Pediatric cardiac surgery with cardiopulmonary bypass is associated with significant morbidity and mortality. Also score systems for risk factors, such as Risk Adjustment for Congenital Heart surgery (RACHS 1) score or the ARISTOTLE score, have been developed, outcome prediction remains difficult. New mathematical methods using deep neural networks associated with Bayesian statistical methods have been developed to give a better understanding of the complex interaction between different risk factors, to identify risk factors and group them in related families. This method has been successfully used to predict mortality in dialysis patient as well as to better describe complex psychiatric syndromes.
The primary hypothesis of this study is that the use of these tools will give a better understanding on the factors affecting outcome after pediatric cardiac surgery.
A network analysis using Gaussian Graphical Models, Mixed Graphical models and Bayesian networks will be used to identify single or groups of risk factors for morbidity and mortality after pediatric cardiac surgery under cardiopulmonary bypass.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Brussels, Belgium, 1020
- Hopital Universitaire des Enfants Reine Fabiola
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 0 to 16 years
- cardiac surgery under cardiopulmonary bypass
Exclusion Criteria:
- ASA (American Society of Anesthesiologists) status 5
- Jehovah's Witness
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Pediatric cardiac surgery
All patients with pediatric cardiac surgery under cardiopulmonary bypass between 2008 and 2018 will be included
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All patients with pediatric cardiac surgery under cardiopulmonary bypass between 2008 and 2018 operated at our institution
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Outcome predictors
Time Frame: 28 days
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All preoperative, peroperative and postoperative variables will be entered into a deep neural network with Bayesian statistics to identify groups or individual risk factors for postoperative morbidity and mortality
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28 days
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- Jenkins KJ, Gauvreau K, Newburger JW, Spray TL, Moller JH, Iezzoni LI. Consensus-based method for risk adjustment for surgery for congenital heart disease. J Thorac Cardiovasc Surg. 2002 Jan;123(1):110-8. doi: 10.1067/mtc.2002.119064.
- Lacour-Gayet F, Clarke D, Jacobs J, Comas J, Daebritz S, Daenen W, Gaynor W, Hamilton L, Jacobs M, Maruszsewski B, Pozzi M, Spray T, Stellin G, Tchervenkov C, Mavroudis And C; Aristotle Committee. The Aristotle score: a complexity-adjusted method to evaluate surgical results. Eur J Cardiothorac Surg. 2004 Jun;25(6):911-24. doi: 10.1016/j.ejcts.2004.03.027.
- Siga MM, Ducher M, Florens N, Roth H, Mahloul N, Fouque D, Fauvel JP. Prediction of all-cause mortality in haemodialysis patients using a Bayesian network. Nephrol Dial Transplant. 2020 Aug 1;35(8):1420-1425. doi: 10.1093/ndt/gfz295.
- Briganti G, Linkowski P. Item and domain network structures of the Resilience Scale for Adults in 675 university students. Epidemiol Psychiatr Sci. 2019 Apr 22;29:e33. doi: 10.1017/S2045796019000222.
- Till AC, Florquin R, Delhaye M, Kornreich C, Williams DR, Briganti G. A network perspective on abnormal child behavior in primary school students. Psychol Rep. 2023 Aug;126(4):1933-1953. doi: 10.1177/00332941221077907. Epub 2022 Mar 24.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- PED_CARDIAC_surg_Bayesian
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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