Executive Summary : | Septic shock is a significant cause of childhood morbidity and mortality, characterized by fluid depletion, vasodilatation, capillary leak, and myocardial dysfunction. Traditional clinical monitoring is insufficient, and continuous non-invasive advanced hemodynamic monitoring based on electrical cardiometry has been validated in children and adults. However, the effectiveness of this protocol in pediatric septic shock management and patient-centered outcomes is unknown. This pilot open-label, parallel-arm, randomized control trial aims to determine if continuous non-invasive advanced hemodynamic monitoring is feasible for pediatric septic shock management. The primary clinical objective is survival free of organ dysfunction censored at 28 days, with other objectives including comparison of mortality, time to shock resolution, organ supports, fluid overload, long-term functional outcomes, and quality of life between groups. The trial will randomize 60 children aged 2 months to 18 years with a diagnosis of septic shock, unresolved after initial 20ml/kg isotonic fluid bolus. The intervention arm will be connected to continuous non-invasive advanced hemodynamic monitor based on electrical cardiometry, providing measurements of cardiac output, stroke volume variability, systemic vascular resistance, index of contractility, and thoracic fluid content. The control arm will be managed as per standard institutional protocols. The study findings may help better understand pediatric septic shock phenotypes, treatment response, and inform future larger multicenter trials. Institute ethics approval will be sought, and informed consent will be obtained from all participants. |