Cardiopulmonary Bypass Clinical Trial
Official title:
Use of Deep Neural Networks and Bayesian Analysis to Identify Risk Factors for Poor Outcome After Pediatric Cardiac Surgery
Verified date | July 2023 |
Source | Brugmann University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 1364 |
Est. completion date | April 30, 2023 |
Est. primary completion date | March 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 16 Years |
Eligibility | Inclusion Criteria: - 0 to 16 years - cardiac surgery under cardiopulmonary bypass Exclusion Criteria: - ASA (American Society of Anesthesiologists) status 5 - Jehovah's Witness |
Country | Name | City | State |
---|---|---|---|
Belgium | Hôpital Universitaire des Enfants Reine Fabiola | Brussels |
Lead Sponsor | Collaborator |
---|---|
Brugmann University Hospital | Université Libre de Bruxelles |
Belgium,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 28 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04084301 -
Impact of Cardiopulmonary Bypass Flow on Renal Oxygenation, Blood Flow and Tubular Injury
|
N/A | |
Completed |
NCT04062396 -
Comparison of Remowell 2 and Inspire on Delirium and Cognitive Dysfunction
|
N/A | |
Completed |
NCT02518087 -
Increased Adsorption Membranes During Cardiopulmonary Bypass
|
N/A | |
Recruiting |
NCT01231776 -
Acupuncture Improves Sleep in Patients Undergoing Cardiopulmonary Bypass
|
N/A | |
Completed |
NCT00747331 -
Fenoldopam and Splanchnic Perfusion During Cardiopulmonary Bypass
|
Phase 4 | |
Terminated |
NCT00176657 -
The Use of HEMOBAG to Salvage Blood After Cardiac Surgery
|
Phase 2 | |
Completed |
NCT00161733 -
Safety and Hemostatic Efficacy of Fibrin Sealant Vapor Heated, Solvent/Detergent Treated (FS VH S/D) Compared With Currently Licensed TISSEEL VH Fibrin Sealant in Subjects Undergoing Cardiac Surgery
|
Phase 3 | |
Completed |
NCT05525195 -
Influence of Preop Fibrinogen on Blood in Pediatric Cardiac Surgery
|
||
Completed |
NCT04238806 -
Desflurane,Brain Natriuretic Peptide and Cardiac Surgery
|
N/A | |
Completed |
NCT00981474 -
Cerebral Autoregulation Monitoring During Cardiac Surgery
|
N/A | |
Recruiting |
NCT05588011 -
Influence of Oxygenator Selection on Platelet Function and Rotational Thromboelastometry Following Cardiopulmonary Bypass
|
N/A | |
Completed |
NCT02566733 -
Minto Model in Effect Site Mode for Target-Controlled Infusion of Remifentanil During Cardiopulmonary Bypass
|
Phase 4 | |
Terminated |
NCT00385450 -
Cardiopulmonary Bypass-Induced Lymphocytopenia and the Potential Effects of Protease Inhibitor
|
Phase 1 | |
Completed |
NCT00246740 -
Protection of the Heart With Doxycycline During Coronary Artery Bypass Grafting
|
Phase 2 | |
Not yet recruiting |
NCT05075265 -
Pharmacokinetics of Methadone in Adults Undergoing Cardiac Surgery With Extracorporeal Circulation
|
||
Recruiting |
NCT04296071 -
Neutrophil Phenotypic Profiling and Acute Lung Injury in Patients After Cardiopulmonary Bypass (CPB)
|
||
Completed |
NCT05579964 -
The Role of Dexmedetomidine as Myocardial Protector in Pediatric Cardiac Surgery Total Correction of Tetralogy of Fallot
|
Phase 2/Phase 3 | |
Active, not recruiting |
NCT04133740 -
Oxygenation Targets in Cardiac Surgery Patients - a Before-and-after Study
|
Phase 4 | |
Completed |
NCT05033236 -
Platelets and Complement Activation in Coronary Artery Bypass Graft Surgery (CABG)
|
||
Completed |
NCT02979158 -
Preoperative Dual Antiplatelet Therapy: Platelet Function and Influence of Cardiopulmonary Bypass
|
N/A |