Influence of Intraoperative Fluid Balance on the Incidence of Adverse Events in Pediatric Cardiac Surgery
- Conditions
- Congenital Heart Disease in ChildrenSurgeryFluid Overload
- Interventions
- Registration Number
- NCT05142046
- Lead Sponsor
- Brugmann University Hospital
- Brief Summary
The intraoperative fluid balance during pediatric cardiac surgery is a very sensitive parameter given the low circulating volume and the complexity of anesthetic management but might be deleterious if inadequately managed. The hypothesis is that a highly positive intraoperative fluid balance increases the incidence of adverse events in the short and long term.
A retrospective observational study including all consecutive children admitted for cardiac surgery with cardiopulmonary bypass (CPB) from 2008 to 2018 in a tertiary children's hospital will be performed. A multivariate analysis will be carried out to study the effect of the fluid balance on the incidence of adverse events.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1400
- Children aged 0-16 years and
- Cardiac surgery with cardiopulmonary bypass and
- operated between 2008 and 2018 at the Queen Fabiola University Children's Hospital (tertiary children's hospital)
- ASA (American Society of Anesthesiologists) score of 5
- Jehovah's Witnesses
- incomplete hospital record
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Pediatric cardiac surgery Fluid balance The group consists of all the children who undergo cardiac surgery in our institution from 2008 to 2018. The age limit was from birth to 16 years old.
- Primary Outcome Measures
Name Time Method Severe postoperative morbidity From intervention until 28 days postoperatively Severe postoperative morbidity will be characterized as the presence of two or more of the following situations: respiratory failure, prolonged inotropic support, or renal failure. Respiratory failure will be defined as the requirement for mechanical ventilation for \>82 hours at any time from Pediatric Intensive Care Unit admission to the time of tracheal extubation.
Prolonged inotropic support will be characterized as hemodynamic support by continuous vasoactive drug infusion for \>48 hours postoperatively (excluding dopamine or dobutamine ≤5 μg/kg/min). Renal failure will be characterized as the worst estimated postoperative creatinine clearance (eCCr) value showing a ≥75% reduction compared with the preoperative baseline eCCr.
- Secondary Outcome Measures
Name Time Method Incidence of new infections From intervention until 28 days postoperatively Infection will be characterized as the need for antibiotics other than the usual anti-staphylococcal prophylaxis initiated by the attending intensive care physician for a suspected or proven infection caused by any pathogen or for a clinical syndrome associated with a high probability of infection. Measurement will be the number of patients with new infections corresponding to this definition.
Incidence of new Neurological deficits From intervention until 28 days postoperatively Neurological deficit will be characterized as a transient or permanent functional abnormality in a body region due to a reduction of brain function. The measurement will be the incidence of ischemic stroke, hemorrhagic stroke and cognitive dysfunctions.
Duration of mechanical ventilation From intervention until 28 days postoperatively Delay between the end of the operation and the extubation of the patient.
PICU and hospital length of stay From intervention until 28 days postoperatively Delay between the end of the operation and the exit of the patient of the Pediatric Intensive care Unit and the delay between the end of the operation and the exit of the institution.
Trial Locations
- Locations (1)
Hôpital Universitaire des Enfants Reine Fabiola
🇧🇪Brussels, Belgium