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| Name | Class |
|---|---|
| Fundação de Amparo à Pesquisa do Estado de São Paulo | OTHER_GOV |
The purpose of this study was to compare ACCM/PALS guidelines performed with and without central venous oxygen saturation monitoring on the morbidity and mortality rate of children with severe sepsis and septic shock.
Background: ACCM/PALS guidelines addresses early correction of pediatric septic shock using physical examination supplemented by indirect measures of cardiac output such as central venous or superior vena cava oxygen saturation (ScvO2>70%) in a goal directed approach. However, these endpoints are based on unsupported evidence. The purpose of this study was to compare ACCM/PALS guidelines performed with and without ScvO2 on the morbidity and mortality rate of children with severe sepsis and septic shock.
Methods: Children and adolescents with severe sepsis or fluid-refractory septic shock were recruited at two university-affiliated hospitals and randomly assigned to ACCM/PALS without, or with an ScvO2 goal directed (goal ScvO2 > 70%) resuscitation. Twenty-eight day mortality is the primary end point.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Central venous oxygen saturation continuous monitoring | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 28-day mortality |
| Measure | Description | Time Frame |
|---|---|---|
| Number of organ dysfunction | ||
| Administered treatments | ||
| Duration of cardiovascular agents therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claudio F Oliveira, MD | University of Sao Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto da Criança - HC-FMUSP | São Paulo | São Paulo | 05409-002 | Brazil | ||
| Hospital Universitário - USP |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11794169 | Result | Rivers E, Nguyen B, Havstad S, Ressler J, Muzzin A, Knoblich B, Peterson E, Tomlanovich M; Early Goal-Directed Therapy Collaborative Group. Early goal-directed therapy in the treatment of severe sepsis and septic shock. N Engl J Med. 2001 Nov 8;345(19):1368-77. doi: 10.1056/NEJMoa010307. | |
| 18369591 | Derived | de Oliveira CF, de Oliveira DS, Gottschald AF, Moura JD, Costa GA, Ventura AC, Fernandes JC, Vaz FA, Carcillo JA, Rivers EP, Troster EJ. ACCM/PALS haemodynamic support guidelines for paediatric septic shock: an outcomes comparison with and without monitoring central venous oxygen saturation. Intensive Care Med. 2008 Jun;34(6):1065-75. doi: 10.1007/s00134-008-1085-9. Epub 2008 Mar 28. |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| D012772 | Shock, Septic |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| Duration of mechanical ventilation |
| Length of Pediatric Intensive Care Unit stay |
| Days free of cardiovascular agents |
| Days free of mechanical ventilation |
| São Paulo |
| São Paulo |
| Brazil |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |