Predictive Pre and Peroperative Factors for MODS-2 in Pediatric Cardiac Surgery (FPMODS2)

July 19, 2022 updated by: Denis SCHMARTZ, Brugmann University Hospital

Predictive Pre and Peroperative Factors for Multiple Organ Dysfunction Score 2 (MODS-2) in Pediatric Cardiac Surgery

Pediatric cardiac surgery has a relatively high morbi-mortality. Despite great advances in surgical techniques, today the mortality rate is about 3% and morbidity is about 30-40%. Outcome has been related to demographic factors, like age; peroperative factors, like duration of cardiopulmonary bypass as well as postoperative factors like positive fluid balance. Willems et al defined a new score (MODS2), an outcome score combining either patient's death or a high postoperative morbidity. This morbidity is defined as minimum of 2 organ failures: either respiratory insufficiency, prolonged use of inotropic agents or renal insufficiency. The aim of this study is to identify pre and peroperative factors which are predictors of MODS2. Patients operated between 2008 and 2018 for pediatric cardiac surgery with cardiopulmonary bypass will be included. Variables extracted from our database will be: sex, ASA score, cyanotic cardiac pathology, redo surgery, RACH1 score, use of antifibrinolytic agents, aortic cross-clamping, deep hypothermic circulatory arrest, selective cerebral perfusion, red cell transfusion in the operating room, administration of fresh frozen plasma in the operating room, age, preoperative weight, weight difference between preop weight and weight at postop day 2, emergency surgery, duration of aortic cross clamping, duration of selective cerebral perfusion, duration of cardiopulmonary bypass, duration off deep hypothermic circulatory arrest, duration of surgery, minimal core temperature, cardiopulmonary priming volume, calculated hemodilution, use of red blood cells in the cardiopulmonary bypass priming, preoperative hemoglobin, preoperative hematocrit, preoperative platelet count, preop international normalized ratio, preop fibrinogen, preop creatinin, toal fluid balance, blood loss during surgery. A statistical analysis (see detailed description) will be used to establish a prediction model for MODS2. The variables describing best the MODS2 outcome will be retained.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Detailed statistical analysis:

5 multiple imputations via the mice R package will be performed, which is the most appropriate method for a risk model. We then take the mean of the imputed datasets in order to start the data mining models on one single dataset. All of the variables will be entered in the model. Before to run the data mining models, we will perform three transformations on the continuous variables: 1) standardization; 2) best normalisation via the bestNormalize R package and 3) taking the variable from its power 2 to its power 10. The dataset will be split into a training set (75% of the cases) and test set (25% of the cases). For all tested data mining models, we will use a 10-fold cross-validation method on the training set before applying the retained model on the test set. The following data mining models will be tested: 1) a regression tree, 2) a logistic regression (GLM), 3) a Neural Network (NN); 4) a Support Vector Machine (SVM); 5) a Random Forest (RF); 6) a Multivariate Adaptive Regression Spline model (MARS) and 7) a Non-Linear Support Vector Machine (SVM NL). The models will be drawn with the caret R package. The confusion matrix, reporting the sensibilities, specificities, accuracies will be drawn on the test set based on the models developed on the training set, and the calibration plot will be drawn for three model competitors. The R software (R Core Team, 2019), version 3.6.1. will be used to produce the results.

Study Type

Observational

Enrollment (Actual)

152

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1020
        • Hôpital Universitaire des Enfants Reine Fabiola

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 16 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • patients undergoing pediatric cardiac surgery with cardiopulmonary bypass between 2008 and 2018 at our institution
  • accepting blood transfusions
  • ASA score 1-4

Exclusion Criteria:

  • Jehova's witness
  • ASA 5 status

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pediatric cardiac surgery patients
Patients undergoing pediatric cardiac surgery with cardiopulmonary bypass between 2008 and 2018 at our institution.
Procedure: Pediatric cardiac surgery with cardiopulmonary bypass
All patients undergoing pediatric cardiac surgery with cardiopulmonary bypass will be extracted from our database

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MODS2
Time Frame: 28 days
Occurence of MODS2 (as percentage) will be extracted. A predictive model will be established from the observed preoperative and peroperative variables. A statistical analysis (see detailed description) will be used to establish a prediction model for MODS2. The variables describing best the MODS2 outcome will be retained.
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brugmann University Hospital

Investigators

  • Study Director: Denis Schmartz, MD, CHU Brugmann

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 18, 2022

Primary Completion (ACTUAL)

June 30, 2022

Study Completion (ACTUAL)

July 8, 2022

Study Registration Dates

First Submitted

March 9, 2022

First Submitted That Met QC Criteria

March 9, 2022

First Posted (ACTUAL)

March 17, 2022

Study Record Updates

Last Update Posted (ACTUAL)

July 20, 2022

Last Update Submitted That Met QC Criteria

July 19, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FPMODS2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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