NCT05142046|Completed
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Sponsor study identifier
observational
1,400
1 country
1
Study Start
March 1, 2022
Actual (reported)Primary Completion
April 30, 2022
Actual (reported)Study Completion
June 10, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 10, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 8, 2021
Actual (reported)December 2, 2021
Actual (reported)March 1, 2022
Actual (reported)April 30, 2022
Actual (reported)June 10, 2022
Actual (reported)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
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
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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).
Hôpital Universitaire des Enfants Reine Fabiola
Brussels, 1020, Belgium
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.
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.
Denis Schmartz, MD
Brugmann University Hospital & HUDERF
1,400 participants (actual enrollment reported by the registry).
First Submitted
November 8, 2021
First Posted
December 2, 2021
Study Start
March 1, 2022
Actual (reported)Immersive Care - Virtual Reality(VR) 360 Pediatric Surgery Preparation.
Contact the study team to confirm eligibility.
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.
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.
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.
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.
Primary Completion
April 30, 2022
Actual (reported)Study Completion
June 10, 2022
Actual (reported)Last Updated
July 20, 2022
Record last verified: 2022-07
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Source: ClinicalTrials.gov.
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