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Gender Influence on Morbi-mortality in Pediatric Cardiac Surgery.

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04452539
Enrollment
1500
Registered
2020-06-30
Start date
2020-07-02
Completion date
2020-11-30
Last updated
2021-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gender, Pediatric Cardiac Surgery

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.

Interventions

PROCEDUREPaediatric cardiac surgery

All patients undergoing paediatric cardiac surgery

Sponsors

Brugmann University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 16 Years

Inclusion criteria

* All patients undergoing paediatric cardiac surgery with cardiopulmonary bypass

Exclusion criteria

* Jehova's witness

Design outcomes

Primary

MeasureTime frameDescription
MortalityBeginning of the operation until 5 days postopMortality in paediatric cardiac surgery
MorbidityBeginning of the operation until 5 days postopMajor 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)

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026