Gender Clinical Trial
Official title:
Gender Influence on Mortality and Major Morbidity After Pediatric Cardiac Surgery.
Verified date | January 2021 |
Source | Brugmann University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 1500 |
Est. completion date | November 30, 2020 |
Est. primary completion date | October 30, 2020 |
Accepts healthy volunteers | |
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 |
Country | Name | City | State |
---|---|---|---|
Belgium | Hôpital Universitaire des Enfants Reine Fabiola | Brussels |
Lead Sponsor | Collaborator |
---|---|
Brugmann University Hospital |
Belgium,
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 |
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