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Abstract

Background: We have elaborated a randomized controlled trial (RCT) protocol in pediatric congenital heart disease patients scheduled for surgical repair. In this RCT protocol trans-thoracic echocardiography will be realized perioperatively to guide fluid and hemodynamic therapy in these patients. This RCT will determine the impact of goal directed therapy with echocardiography on postoperative outcome in terms of morbidity, length of intensive care unit stay (LOSICU), length of mechanical ventilation (LMV), length of hospital stay (LOS), fluid therapy and vasopressor-inotropic therapy. There are no trials in this population which have identified echocardiographic hemodynamic parameters predictive of postoperative outcome in terms of morbidity, LOSICU, LMV and LOS. The objective of this pilot observational prospective trial protocol is to describe the study which will determine echocardiographic hemodynamic parameters predictive of postoperative outcomes. These hemodynamic parameters will be integrated in the RCT which has the objective to determine the impact of goal directed fluid and hemodynamic therapy guided by trans-thoracic echocardiography on postoperative adverse outcome. Methods: Patients aged less than 18 years with congenital heart disease admitted for surgical repair will be included. Trans-thoracic echocardiography will be realized to measure different hemodynamic parameters preoperatively and perioperatively after weaning from cardiopulmonary bypass until discharge from the ICU in included patients. Primary outcome will be postoperative morbidity, secondary outcomes will be LOSICU, LMV and LOS; tertiary outcomes will be fluid therapy, vasopressor and inotropic therapy. Primary outcome measure will be the presence of postoperative organ dysfunction. Secondary outcome measures will be the number of postoperative days spent in the intensive care unit (ICU), number of postoperative days spent on invasive or non-invasive mechanical ventilation and the number of postoperative days spent in the conventional hospitalization ward. Tertiary outcome measures will be the quantity of fluid administered and the vasopressor-inotropic score (VIS). The study will be monocentric. XLSAT 2018.3 or plus will be the software for statistic analysis. Results are expected in the first semester of 2021. Conclusion: This pilot study will identify echocardiographic hemodynamic parameters predictive of postoperative adverse outcome which will be integrated in the second RCT where goal directed fluid and hemodynamic therapy will be guided with echocardiography.

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