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

NCT05142046 | Completed

• 1 other identifier: CHUB_PED_Liquids-Cardiac
• Study Type: observational
• Target: 1,400
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Heart Disease in Children; Surgery; Fluid Overload

Outcome Measures

Primary Outcomes (1)

• Severe postoperative morbidity

  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.

  From intervention until 28 days postoperatively

Secondary Outcomes (4)

• Incidence of new Neurological deficits

  From intervention until 28 days postoperatively

• Incidence of new infections

  From intervention until 28 days postoperatively

• Duration of mechanical ventilation

  From intervention until 28 days postoperatively

• PICU and hospital length of stay

  From intervention until 28 days postoperatively

Study Arms (1)

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

Interventions

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.

Pediatric cardiac surgery

Eligibility Criteria

• Age: Up to 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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).

You may qualify if:

• 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)

You may not qualify if:

• ASA (American Society of Anesthesiologists) score of 5
• Jehovah's Witnesses
• incomplete hospital record

Sponsors & Collaborators

• Brugmann University Hospital: lead

Study Sites (1)

Hôpital Universitaire des Enfants Reine Fabiola

Brussels, 1020, Belgium

Location

Related Publications (6)

• 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.

  PMID: 17040306 BACKGROUND

• 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.

  PMID: 24280709 BACKGROUND

• 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.

  PMID: 26914622 BACKGROUND

• 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.

  PMID: 22651844 BACKGROUND

• 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.

  PMID: 12393365 BACKGROUND

• 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.

  PMID: 25072753 BACKGROUND

MeSH Terms

Conditions

Edema

Interventions

Water-Electrolyte Balance

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Osmoregulation; Biochemical Phenomena; Chemical Phenomena; Metabolism; Homeostasis; Physiological Phenomena

Study Officials

• Denis Schmartz, MD

  Brugmann University Hospital & HUDERF

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, Department of Anesthesiology

Study Record Dates

• First Submitted: November 8, 2021
• First Posted: December 2, 2021
• Study Start: March 1, 2022
• Primary Completion: April 30, 2022
• Study Completion: June 10, 2022
• Last Updated: July 20, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)