CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,400 enrolled
Drug / intervention
Fluid balancedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05142046
NCT05142046N/ACompleted

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

Brugmann University Hospital·observational·Posted Dec 2, 2021·Updated Jul 20, 2022

In Brief

An observational study evaluating Fluid balance for Congenital Heart Disease in Children and 2 related conditions. Completed, enrolled 1,400 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesBelgium
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedDec 2, 2021
Enrollment StartMar 1, 2022
Primary CompletionApr 30, 2022
Study CompletionJun 10, 2022
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 4.6 years ago

Interventions

Fluid balancedrug

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.