Clinical trial NCT05142046: Influence of Intraoperative Fluid Balance on the Incidence of Adverse Events in Pediatric Cardiac Surgery
Official title: Influence of Intraoperative Fluid Balance on the Incidence of Adverse Events in Pediatric Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Heart Disease in Children
Surgery
Fluid Overload
Lead sponsor: Brugmann University Hospital
Sponsor class: OTHER
First posted: 2021-12-02
Enrollment: 1400
Sex: ALL
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The cohort consist of every child aged between 0-16 years who undergoes CPB-assisted cardiac surgery from 2008 to 2018 in Queen Fabiola University Children's Hospital (tertiary children's hospital).

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.


Eligibility criteria: 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

Primary outcomes:
measure: Severe postoperative morbidity
timeFrame: From intervention until 28 days postoperatively
Secondary outcomes:
measure: Incidence of new Neurological deficits
timeFrame: From intervention until 28 days postoperatively
measure: Incidence of new infections
timeFrame: From intervention until 28 days postoperatively
measure: Duration of mechanical ventilation
timeFrame: From intervention until 28 days postoperatively
measure: PICU and hospital length of stay
timeFrame: From intervention until 28 days postoperatively
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Hôpital Universitaire des Enfants Reine Fabiola
Study officials:
affiliation: Brugmann University Hospital & HUDERF
name: Denis Schmartz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.