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

Sponsor
Brugmann University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05142046
Collaborator
(none)
1,400
1
3.3
421.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Fluid balance

Study Design

Study Type:
Observational
Actual Enrollment :
1400 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Influence of Intraoperative Fluid Balance on the Incidence of Adverse Events in Pediatric Cardiac Surgery
Actual Study Start Date :
Mar 1, 2022
Actual Primary Completion Date :
Apr 30, 2022
Actual Study Completion Date :
Jun 10, 2022

Arms and Interventions

Arm Intervention/Treatment
Pediatric cardiac surgery

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.

Drug: Fluid 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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. 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.

  3. Duration of mechanical ventilation [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 16 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hôpital Universitaire des Enfants Reine Fabiola Brussels Belgium 1020

Sponsors and Collaborators

  • Brugmann University Hospital

Investigators

  • Principal Investigator: Denis Schmartz, MD, Brugmann University Hospital & HUDERF

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Denis SCHMARTZ, Head, Department of Anesthesiology, Brugmann University Hospital
ClinicalTrials.gov Identifier:
NCT05142046
Other Study ID Numbers:
  • CHUB_PED_Liquids-Cardiac
First Posted:
Dec 2, 2021
Last Update Posted:
Jul 20, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 20, 2022