Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Norepinephrine Group (Fluid loading with early norepinephrine administration group) | Experimental | NE Group will receive ringer lactate bolus 20 ml/kg along with norepinephrine infusion at 0.1 mcg/kg/ minute until MAP>5 percentile. Additional fluid boluses of 10-20 ml/kg will be administered (up to a total of 60 ml/kg) until shock resolution or signs of fluid overload are observed, with or without continued norepinephrine infusion according to the treatment group |
|
| Ringer's lactate Group | Active Comparator | The Fluid Group will receive only ringer lactate bolus 20 ml/kg. Additional fluid boluses of 10-20 ml/kg will be administered (up to a total of 60 ml/kg) until shock resolution or signs of fluid overload are observed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Norepinephrine | Drug | NE Group (Fluid loading with early norepinephrine administration group) NE Group will receive ringer lactate bolus 20 ml/kg along with norepinephrine infusion at 0.1 mcg/kg/minute until MAP>5 percentile. Additional fluid boluses of 10-20 ml/kg will be administered (up to a total of 60 ml/kg) until shock resolution or signs of fluid overload are observed, with or without continued norepinephrine infusion according to the treatment group |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Patients aged 3 months to 18 years with critical condition
Suspected or confirmed infection, indicated by fever accompanied by signs of shock:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cipto Mangunkusumo Hospital | Jakarta Pusat | DKI Jakarta | 10440 | Indonesia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20378998 | Background | Sugimoto M, Manabe H, Nakau K, Furuya A, Okushima K, Fujiyasu H, Kakuya F, Goh K, Fujieda K, Kajino H. The role of N-terminal pro-B-type natriuretic peptide in the diagnosis of congestive heart failure in children. - Correlation with the heart failure score and comparison with B-type natriuretic peptide -. Circ J. 2010 May;74(5):998-1005. doi: 10.1253/circj.cj-09-0535. Epub 2010 Apr 6. | |
| 21615299 |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012772 | Shock, Septic |
| D018805 | Sepsis |
| D011654 | Pulmonary Edema |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
Not provided
Not provided
| ID | Term |
|---|---|
| D009638 | Norepinephrine |
| D000077325 | Ringer's Lactate |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
Not provided
Not provided
Interventional subject will be received fluid loading with early norepinephrine administration with dose 0.1 mcg/kgBW/minute control subject will be received fluid loading only
Not provided
Not provided
fluid loading with norepinephrie
Not provided
|
| Ringer's Lactate | Drug | Fluid Group will receive ringer lactate bolus 20 ml/ kg only. Additional fluid boluses of 10-20 ml/kg will be administered (up to a total of 60 ml/kg) until shock resolution or signs of fluid overload are observed |
|
pulmonary edema shown by B-line using lung ultrasound
| evaluate one hour after intervention |
| Result |
| Maitland K, Kiguli S, Opoka RO, Engoru C, Olupot-Olupot P, Akech SO, Nyeko R, Mtove G, Reyburn H, Lang T, Brent B, Evans JA, Tibenderana JK, Crawley J, Russell EC, Levin M, Babiker AG, Gibb DM; FEAST Trial Group. Mortality after fluid bolus in African children with severe infection. N Engl J Med. 2011 Jun 30;364(26):2483-95. doi: 10.1056/NEJMoa1101549. Epub 2011 May 26. |
| 36507525 | Result | Macdonald S, Peake SL, Corfield AR, Delaney A. Fluids or vasopressors for the initial resuscitation of septic shock. Front Med (Lausanne). 2022 Nov 24;9:1069782. doi: 10.3389/fmed.2022.1069782. eCollection 2022. |
| 25407570 | Result | Garcia MI, Romero MG, Cano AG, Aya HD, Rhodes A, Grounds RM, Cecconi M. Dynamic arterial elastance as a predictor of arterial pressure response to fluid administration: a validation study. Crit Care. 2014 Nov 19;18(6):626. doi: 10.1186/s13054-014-0626-6. |
| 28367008 | Result | Choudhary R, Sitaraman S, Choudhary A. Lactate clearance as the predictor of outcome in pediatric septic shock. J Emerg Trauma Shock. 2017 Apr-Jun;10(2):55-59. doi: 10.4103/JETS.JETS_103_16. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000588 |
| Amines |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |