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Influence of Intraoperative Fluid Balance on the Incidence of Adverse Events in Pediatric Cardiac Surgery

Influence of Intraoperative Fluid Balance on the Incidence of Adverse Events in Pediatric Cardiac Surgery

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05142046
Enrollment
1400
Registered
2021-12-02
Start date
2022-03-01
Completion date
2022-06-10
Last updated
2022-07-20

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

Conditions

Congenital Heart Disease in Children, Fluid Overload, Surgery

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.

Interventions

DRUGFluid balance

The intervention consists of classic and standardized anesthesia management of children undergoing cardiac surgery. All the data links to the fluid management will be extracted from the patient's chart in the intraoperative period as well as complications during the hospitalization in the postoperative period.

Sponsors

Brugmann University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 16 Years
Healthy volunteers
No

Inclusion criteria

* 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)

Exclusion criteria

* ASA (American Society of Anesthesiologists) score of 5 * Jehovah's Witnesses * incomplete hospital record

Design outcomes

Primary

MeasureTime frameDescription
Severe postoperative morbidityFrom intervention until 28 days postoperativelySevere 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

MeasureTime frameDescription
Incidence of new Neurological deficitsFrom intervention until 28 days postoperativelyNeurological 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.
Incidence of new infectionsFrom intervention until 28 days postoperativelyInfection 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.
Duration of mechanical ventilationFrom intervention until 28 days postoperativelyDelay between the end of the operation and the extubation of the patient.
PICU and hospital length of stayFrom intervention until 28 days postoperativelyDelay 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.

Countries

Belgium

Outcome results

None listed

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