Bayesian Networks in Pediatric Cardiac Surgery

Sponsor
Brugmann University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05537168
Collaborator
Université Libre de Bruxelles (Other)
2,000
1
3.4
579.8

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Pediatric cardiac surgery under cardiopulmonary bypass

Study Design

Study Type:
Observational
Anticipated Enrollment :
2000 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Use of Deep Neural Networks and Bayesian Analysis to Identify Risk Factors for Poor Outcome After Pediatric Cardiac Surgery
Actual Study Start Date :
Sep 17, 2022
Anticipated Primary Completion Date :
Oct 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Pediatric cardiac surgery

All patients with pediatric cardiac surgery under cardiopulmonary bypass between 2008 and 2018 will be included

Procedure: Pediatric cardiac surgery under cardiopulmonary bypass
All patients with pediatric cardiac surgery under cardiopulmonary bypass between 2008 and 2018 operated at our institution

Outcome Measures

Primary Outcome Measures

  1. Outcome predictors [28 days]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 16 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • 0 to 16 years

  • cardiac surgery under cardiopulmonary bypass

Exclusion Criteria:
  • ASA (American Society of Anesthesiologists) status 5

  • Jehovah's Witness

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hôpital Universitaire des Enfants Reine Fabiola Brussels Belgium 1020

Sponsors and Collaborators

  • Brugmann University Hospital
  • Université Libre de Bruxelles

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Denis SCHMARTZ, Head, Département of Anesthesiology, Brugmann University Hospital
ClinicalTrials.gov Identifier:
NCT05537168
Other Study ID Numbers:
  • PED_CARDIAC_surg_Bayesian
First Posted:
Sep 13, 2022
Last Update Posted:
Sep 19, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Sep 19, 2022