Gender Influence on Morbi-mortality in Pediatric Cardiac Surgery.

Completed

• Conditions: Gender; Pediatric Cardiac Surgery
• Interventions: Procedure: Paediatric cardiac surgery

• Registration Number: NCT04452539
• Lead Sponsor: Brugmann University Hospital

Brief Summary

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.

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 Timeline

• Study First Submitted: 2020-06-26
• Study First Submitted QC: 2020-06-26
• Study First Posted: 2020-06-30
• Study Start: 2020-07-02
• Primary Completion: 2020-10-30
• Study Completion: 2020-11-30
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-27
• Last Update Posted: 2021-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

• All patients undergoing paediatric cardiac surgery with cardiopulmonary bypass

Exclusion Criteria

• Jehova's witness

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Paediatric cardiac surgery patients	Paediatric cardiac surgery	All patients undergoing paediatric cardiac surgery

Primary Outcome Measures

Name	Time	Method
Mortality	Beginning of the operation until 5 days postop	Mortality in paediatric cardiac surgery
Morbidity	Beginning of the operation until 5 days postop	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)

Trial Locations

Locations (1)

Hôpital Universitaire des Enfants Reine Fabiola; 🇧🇪 Brussels, Belgium