CClinicalTrials.gg
CompletedNCT05537168Updated Jul 27, 2023

Bayesian Networks in Pediatric Cardiac Surgery

An observational study in Cardiac Surgical Procedures, Pediatrics and Cardiopulmonary Bypass, sponsored by Brugmann University Hospital. Completed at 1 site in Belgium. Open to participants aged Up to 16 Years. Per ClinicalTrials.gov, last updated 2023-07-27.

Sponsored by Brugmann University Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
1,364
Ages
Up to 16 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Cardiac Surgical Procedures
  • Pediatrics
  • Cardiopulmonary Bypass
03

In context

Lead sponsor

Brugmann University Hospital is the lead sponsor of 116 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 16 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

  • 0 to 16 years
  • cardiac surgery under cardiopulmonary bypass

Exclusion criteria

Exclusion Criteria:

  • ASA (American Society of Anesthesiologists) status 5
  • Jehovah's Witness
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
1,364 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • ProcedurePediatric cardiac surgery under cardiopulmonary bypass

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

06

What researchers measure

Primary outcomes

  1. Outcome predictors

    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

    Time frame: 28 days

07

Study locations

1 site
  • Hôpital Universitaire des Enfants Reine Fabiola
    Brussels, 1020, Belgium
08

References and documents

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. PubMed 11782764 ↗
  • 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. PubMed 15144988 ↗
  • 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. PubMed 32040147 ↗
  • 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. PubMed 35331028 ↗
  • 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. PubMed 31006419 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05537168
Lead sponsor
Brugmann University Hospital
Collaborators
Université Libre de Bruxelles
Responsible party
Denis SCHMARTZ (Head, Département of Anesthesiology, Brugmann University Hospital) — Principal investigator
First posted
Sep 13, 2022
Start date
Sep 17, 2022
Primary completion
Mar 31, 2023
Completion
Apr 30, 2023
Last update
Jul 27, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion