Gender Influence on Morbi-mortality in Pediatric Cardiac Surgery.

Overview

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

Full Title of Study: “Gender Influence on Mortality and Major Morbidity After Pediatric Cardiac Surgery.”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: September 30, 2020

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. We hypothesise that there is a gender influence on mortality and major morbidity in paediatric patients undergoing cardiac surgery. We will do a retrospective cohort study, analysing our 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:

We 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.

Interventions

  • Procedure: Paediatric cardiac surgery
    • All patients undergoing paediatric cardiac surgery

Arms, Groups and Cohorts

  • Paediatric cardiac surgery patients
    • All patients undergoing paediatric cardiac surgery

Clinical Trial Outcome Measures

Primary Measures

  • Mortality
    • Time Frame: Beginning of the operation until 5 days postop
    • Mortality in paediatric cardiac surgery
  • Morbidity
    • Time Frame: 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)

Participating in This Clinical Trial

Inclusion Criteria

  • All patients undergoing paediatric cardiac surgery with cardiopulmonary bypass

Exclusion Criteria

  • Jehova's witness

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 16 Years

Investigator Details

  • Lead Sponsor
    • Brugmann University Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Denis SCHMARTZ, Head, Department of Anesthesiology – Brugmann University Hospital
  • Overall Official(s)
    • Denis Schmartz, MD, Principal Investigator, CHU Brugmann
  • Overall Contact(s)
    • Denis Schmartz, MD, 3224773996, denis.schmartz@chu-brugmann.be

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