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NCT Number: NCT05142046

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

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.

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Key information

Conditions

Congenital Heart Disease in Children Edema Fluid Overload Pathological Conditions, Signs and Symptoms Signs and Symptoms Surgery

Age range

Up to 16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Universitaire des Enfants Reine Fabiola

Brussels, 1020, Belgium

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Fluid balance

Drug

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.

Primary outcomes

  1. Severe postoperative morbidity

    Time frame: 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 outcomes

  1. Incidence of new Neurological deficits

    Time frame: 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.

  2. Incidence of new infections

    Time frame: 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.

  3. Duration of mechanical ventilation

    Time frame: From intervention until 28 days postoperatively

    Delay between the end of the operation and the extubation of the patient.

  4. PICU and hospital length of stay

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Brugmann University Hospital

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Dec 2, 2021
Registry last updated
Jul 20, 2022

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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