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NCT Number: NCT04452539

Gender Influence on Morbi-mortality in 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.

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Key information

Age range

Up to 16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Universitaire des Enfants Reine Fabiola

Brussels, 1020, Belgium

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients undergoing paediatric cardiac surgery with cardiopulmonary bypass

Exclusion criteria

  • Jehova's witness

Treatment and study plan

Paediatric cardiac surgery

Procedure

All patients undergoing paediatric cardiac surgery

Primary outcomes

  1. Mortality

    Time frame: Beginning of the operation until 5 days postop

    Mortality in paediatric cardiac surgery

  2. 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)

Sponsors and collaborators

Lead sponsor

Brugmann University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 30, 2020
Registry last updated
Jan 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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