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Clinical Trials/NCT04452539
NCT04452539
Completed
Not Applicable

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

Brugmann University Hospital1 site in 1 country1,500 target enrollmentJuly 2, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pediatric Cardiac Surgery
Sponsor
Brugmann University Hospital
Enrollment
1500
Locations
1
Primary Endpoint
Mortality
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2, 2020
End Date
November 30, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Denis SCHMARTZ

Head, Department of Anesthesiology

Brugmann University Hospital

Eligibility Criteria

Inclusion Criteria

  • All patients undergoing paediatric cardiac surgery with cardiopulmonary bypass

Exclusion Criteria

  • Jehova's witness

Outcomes

Primary Outcomes

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)

Study Sites (1)

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