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

NCT ID: NCT05142046

Last Updated: 2022-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-01

Study Completion Date

2022-06-10

Brief Summary

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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

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Conditions

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Congenital Heart Disease in Children Surgery Fluid Overload

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Fluid balance

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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
Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Brugmann University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Denis SCHMARTZ

Head, Department of Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Denis Schmartz, MD

Role: PRINCIPAL_INVESTIGATOR

Brugmann University Hospital & HUDERF

Locations

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Hôpital Universitaire des Enfants Reine Fabiola

Brussels, , Belgium

Site Status

Countries

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Belgium

References

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Szekely A, Sapi E, Kiraly L, Szatmari A, Dinya E. Intraoperative and postoperative risk factors for prolonged mechanical ventilation after pediatric cardiac surgery. Paediatr Anaesth. 2006 Nov;16(11):1166-75. doi: 10.1111/j.1460-9592.2006.01957.x.

Reference Type BACKGROUND
PMID: 17040306 (View on PubMed)

Agarwal HS, Wolfram KB, Saville BR, Donahue BS, Bichell DP. Postoperative complications and association with outcomes in pediatric cardiac surgery. J Thorac Cardiovasc Surg. 2014 Aug;148(2):609-16.e1. doi: 10.1016/j.jtcvs.2013.10.031. Epub 2013 Nov 23.

Reference Type BACKGROUND
PMID: 24280709 (View on PubMed)

Lex DJ, Toth R, Czobor NR, Alexander SI, Breuer T, Sapi E, Szatmari A, Szekely E, Gal J, Szekely A. Fluid Overload Is Associated With Higher Mortality and Morbidity in Pediatric Patients Undergoing Cardiac Surgery. Pediatr Crit Care Med. 2016 Apr;17(4):307-14. doi: 10.1097/PCC.0000000000000659.

Reference Type BACKGROUND
PMID: 26914622 (View on PubMed)

Stein A, de Souza LV, Belettini CR, Menegazzo WR, Viegas JR, Costa Pereira EM, Eick R, Araujo L, Consolim-Colombo F, Irigoyen MC. Fluid overload and changes in serum creatinine after cardiac surgery: predictors of mortality and longer intensive care stay. A prospective cohort study. Crit Care. 2012 May 31;16(3):R99. doi: 10.1186/cc11368.

Reference Type BACKGROUND
PMID: 22651844 (View on PubMed)

Holte K, Sharrock NE, Kehlet H. Pathophysiology and clinical implications of perioperative fluid excess. Br J Anaesth. 2002 Oct;89(4):622-32. doi: 10.1093/bja/aef220. No abstract available.

Reference Type BACKGROUND
PMID: 12393365 (View on PubMed)

Seguin J, Albright B, Vertullo L, Lai P, Dancea A, Bernier PL, Tchervenkov CI, Calaritis C, Drullinsky D, Gottesman R, Zappitelli M. Extent, risk factors, and outcome of fluid overload after pediatric heart surgery*. Crit Care Med. 2014 Dec;42(12):2591-9. doi: 10.1097/CCM.0000000000000517.

Reference Type BACKGROUND
PMID: 25072753 (View on PubMed)

Other Identifiers

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CHUB_PED_Liquids-Cardiac

Identifier Type: -

Identifier Source: org_study_id

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