Surgery Clinical Trial
Official title:
Influence of Intraoperative Fluid Balance on the Incidence of Adverse Events in Pediatric Cardiac Surgery
Verified date | July 2022 |
Source | Brugmann University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 1400 |
Est. completion date | June 10, 2022 |
Est. primary completion date | April 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 16 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Belgium | Hôpital Universitaire des Enfants Reine Fabiola | Brussels |
Lead Sponsor | Collaborator |
---|---|
Brugmann University Hospital |
Belgium,
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. — View Citation
Holte K, Sharrock NE, Kehlet H. Pathophysiology and clinical implications of perioperative fluid excess. Br J Anaesth. 2002 Oct;89(4):622-32. Review. — View Citation
Lex DJ, Tóth R, Czobor NR, Alexander SI, Breuer T, Sápi E, Szatmári A, Székely E, Gál J, Székely 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. — View 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. — View Citation
Stein A, de Souza LV, Belettini CR, Menegazzo WR, Viégas JR, Costa Pereira EM, Eick R, Araújo 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. — View Citation
Székely A, Sápi E, Király L, Szatmári A, Dinya E. Intraoperative and postoperative risk factors for prolonged mechanical ventilation after pediatric cardiac surgery. Paediatr Anaesth. 2006 Nov;16(11):1166-75. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Incidence of new Neurological deficits | Neurological deficit will be characterized as a transient or permanent functional abnormality in a body region due to a reduction of brain function. The measurement will be the incidence of ischemic stroke, hemorrhagic stroke and cognitive dysfunctions. | From intervention until 28 days postoperatively | |
Secondary | Incidence of new infections | Infection will be characterized as the need for antibiotics other than the usual anti-staphylococcal prophylaxis initiated by the attending intensive care physician for a suspected or proven infection caused by any pathogen or for a clinical syndrome associated with a high probability of infection. Measurement will be the number of patients with new infections corresponding to this definition. | From intervention until 28 days postoperatively | |
Secondary | Duration of mechanical ventilation | Delay between the end of the operation and the extubation of the patient. | From intervention until 28 days postoperatively | |
Secondary | PICU and hospital length of stay | Delay between the end of the operation and the exit of the patient of the Pediatric Intensive care Unit and the delay between the end of the operation and the exit of the institution. | From intervention until 28 days postoperatively |
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