The Effect of Early Norepinephrine on Stroke Volume Index, Cardiac Index, Lactate, and Arterial Elastance in Pediatric Septic Shock
NCT Number: NCT06461390
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE2|PHASE3
Conditions: Septic Shock|Sepsis
Interventions: DRUG: Norepinephrine|DRUG: Ringer's Lactate
Sponsor: Indonesia University
Sex: ALL
Age: CHILD, ADULT
Enrollment: 42
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-03-25
Completion Date: 2024-05-31
Locations: Cipto Mangunkusumo Hospital, Jakarta Pusat, DKI Jakarta, 10440, Indonesia

Summary:
The complexity of pediatric septic shock arise from its varied pathophysiology, which includes systemic inflammation, cardiovascular collapse, and multiple organ dysfunction. Current standard treatments, which primarily focusedon fluid resuscitation, had exhibited several problems. Excessive fluid resuscitation has been associated with complications such as fluid overload, which may cause conditions such as pulmonary edema and organ dysfunction, leading to worsened outcomes. This emphasizes the need for alternative therapeutic strategies that can effectively manage hemodynamic instability while minimizing the risks of fluid overload. In adult patients, the early use of vasopressors has been recommended to restore perfusion in patients with septic shock, compared to repeated fluid loading. However, previous research on the use of norepinephrine and the preload status of the pediatric population is still limited. In addition, the use of fluid resuscitation does not always exhibit the desirable response, which is the increase of blood pressure. This is because the blood pressure depends not only on the stroke volume but also the vascular resistance. Consequently, predicting blood pressure elevation after fluid resuscitation remains challenging. Based on previous research, arterial elastance has the potential to predict the increase of blood pressure in response to fluid administration. Thus, this study aimed to investigate the effects of early administration of fluid resuscitation combined with norepinephrine in pediatric septic shock patients and evaluate the useof arterial elastance as a predictor of blood pressure response following fluid resuscitation. Finally, this study will also evaluate the parameters such as stroke volume index, cardiac index, lactate clearance , arterial elastance in pediatric patients with septic shock who were resuscitated using the hemodynamic support guidelines according to the Surviving Sepsis Campaign protocols.

Primary Outcome Measures: stroke volume index, Evaluate the changes in stroke volume index using Ultrasonic Cardiac Output Monitor (USCOM), in units ml/m2, between the pediatric septic shock patients receiving fluid loading with early norepinephrine compared to those who only receive fluid loading, evaluate one hour after intervention|cardiac index, Evaluate the changes in cardiac index Ultrasonic Cardiac Output Monitor (USCOM), in units L/m2/minute,between the pediatric septic shock patients receiving fluid loading with early norepinephrine compared to those who only receive fluid loading, evaluate one hour after intervention|Lactate, Lactate clearance is defined as the change in lactate levels between two time points and is expressed as a 10-20% reduction in lactate per hour or a reduction of at least 10% within 6 hours during initial resuscitation, evaluate one hour after intervention
Secondary Outcome Measures: arterial elastance, Arterial elastance is obtained using the formula: (0.9 x systolic blood pressure)/stroke volume or mean arterial pressure/stroke volume, evaluate one hour after intervention|pulmonary edema, pulmonary edema shown by B-line using lung ultrasound, evaluate one hour after intervention