Gender Influence on Morbi-mortality in Pediatric Cardiac Surgery.

Gender Influence on Mortality and Major Morbidity After Pediatric Cardiac Surgery.

Recent studies show an important influence of gender on inflammatory reactions. Cardiac surgery is associated with a major systemic inflammatory response. The investigators want to evaluate the gender influence on morbi-mortality in pediatric cardiac surgery patients.

Study Overview

• Status: Completed
• Conditions: Pediatric Cardiac Surgery; Gender
• Intervention / Treatment: Procedure: Paediatric cardiac surgery

Detailed Description

Gender plays an important role in the inflammatory response. This is due to hormonal influences, but also different genetic regulation of pro-inflammatory cytokines, as nuclear facto kapp B. it is also know that cardiac surgery, especially under cardiopulmonary bypass, is associated with a major inflammatory response. This response is even more marked in pediatric cardiac surgery. The investigators hypothesise that there is a gender influence on mortality and major morbidity in paediatric patients undergoing cardiac surgery. The investigators will do a retrospective cohort study, analysing the local database of all paediatric cardiac surgery cases from jan 2006 to dec 2019. Primary outcome will be any difference in mortality and /or major morbidity according to gender.

Statistical analysis:

The investigators will use a propensity score on 11 pre-operative variables clinically judged relevant. Both group will be matched until a absolute standardised difference < 15% is obtained. This type of matching, contrary to a P value, is independent of sample size. Variables will be presented as mean, standard deviation or percentage for frequency distributions. After propensity score matching, logistic regressions will be performed on binary variables and linear regressions on continuous variables. A Bonferroni correction will be used for multiple comparisons.

• Study Type: Observational
• Enrollment (Actual): 1500

Contacts and Locations

Study Locations

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

Participation Criteria

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 paediatric cardiac surgery with cardiopulmonary bypas at our institution from jan 2006 to dec 2019.

Description

Inclusion Criteria:

• All patients undergoing paediatric cardiac surgery with cardiopulmonary bypass

Exclusion Criteria:

• Jehova's witness

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Paediatric cardiac surgery patients; All patients undergoing paediatric cardiac surgery	Procedure: Paediatric cardiac surgery; All patients undergoing paediatric cardiac surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Mortality in paediatric cardiac surgery	Beginning of the operation until 5 days postop
Morbidity	Major morbidity in paediatric cardiac surgery, defined as at least 2 of the following conditions: Respiratory failure (mechanical ventilation > 90h), prolonged inotropic support (> 5 mcg/kg/min of dobutamine for more than 48h postop), renal insufficiency (Drop in glomerular filtration rate > 75% compared to preop values)	Beginning of the operation until 5 days postop

Collaborators and Investigators

• Sponsor: Brugmann University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2020
• Primary Completion (Actual): October 30, 2020
• Study Completion (Actual): November 30, 2020

Study Registration Dates

• First Submitted: June 26, 2020
• First Submitted That Met QC Criteria: June 26, 2020
• First Posted (Actual): June 30, 2020

Study Record Updates

• Last Update Posted (Actual): January 28, 2021
• Last Update Submitted That Met QC Criteria: January 27, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: CHUB_GENDERPED

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
• product manufactured in and exported from the U.S.: No