Gender Influence on Morbi-mortality in Pediatric Cardiac Surgery.

Gender Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04452539
• Other study ID #: CHUB_GENDERPED
• Status: Completed
• Start date: July 2, 2020
• Est. completion date: November 30, 2020

Study information

• Verified date: January 2021
• Source: Brugmann University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1500
• Est. completion date: November 30, 2020
• Est. primary completion date: October 30, 2020
• Gender: All
• Age group: N/A to 16 Years

Eligibility

Inclusion Criteria:

• All patients undergoing paediatric cardiac surgery with cardiopulmonary bypass

Exclusion Criteria:

• Jehova's witness

Related Conditions & MeSH terms

• Gender
• Pediatric Cardiac Surgery

Intervention

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

Locations

Country	Name	City	State
Belgium	Hôpital Universitaire des Enfants Reine Fabiola	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Brugmann University Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Mortality in paediatric cardiac surgery	Beginning of the operation until 5 days postop
Primary	Morbidity	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)	Beginning of the operation until 5 days postop