Ignite Creation Date:
2024-07-17 @ 10:55 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06461390
Status:
COMPLETED
Last Update Posted:
2024-06-20
First Post:
2024-06-04
Brief Title:
The Effect of Early Norepinephrine on Stroke Volume Index Cardiac Index Lactate and Arterial Elastance in Pediatric Septic Shock
Sponsor:
Indonesia University
Organization:
Indonesia University
Study Overview
Official Title:
The Effect of Fluid Loading With Early Norepinephrine Administration on Stroke Volume Index Cardiac Index Lactate and Arterial Elastance in Pediatric Septic Shock
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
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 focused on 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 volumebut 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 use of 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
Research Objectives
1 Evaluate the changes in preload between the pediatric septic shock patients receiving fluid loading with early administration of norepinephrine compared to those who only receive fluid loading
2 Evaluate the changes in stroke volume index cardiac index and mean arterial pressure between the pediatric before and after treatment in both groups
3 Evaluate the changes in lactate clearance before and after treatment in both groups
4 Assess the sensitivity and specificity of arterial elastance as a predictor of blood pressure response in patients receiving fluid resuscitation
Research Objectives
1 Evaluate the changes in preload between the pediatric septic shock patients receiving fluid loading with early administration of norepinephrine compared to those who only receive fluid loading
2 Evaluate the changes in stroke volume index cardiac index and mean arterial pressure between the pediatric before and after treatment in both groups
3 Evaluate the changes in lactate clearance before and after treatment in both groups
4 Assess the sensitivity and specificity of arterial elastance as a predictor of blood pressure response in patients receiving fluid resuscitation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None