Comparison of Pediatric Septic Shock Treatment With and Without Central Venous Oxygen Saturation Monitoring
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| First Received Date ICMJE | December 4, 2006 | ||||
| Last Updated Date | December 4, 2006 | ||||
| Start Date ICMJE | January 2004 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
28-day mortality | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Comparison of Pediatric Septic Shock Treatment With and Without Central Venous Oxygen Saturation Monitoring | ||||
| Official Title ICMJE | An Outcomes Comparison of ACCM/PALS Guidelines For Pediatric Septic Shock With and Without Central Venous Oxygen Saturation Monitoring | ||||
| Brief Summary | 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. |
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| Detailed Description | 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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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Procedure: Central venous oxygen saturation continuous monitoring | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 268 | ||||
| Completion Date | August 2005 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 1 Month to 19 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Brazil | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00407823 | ||||
| Other Study ID Numbers ICMJE | 2004/07949-7 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | University of Sao Paulo | ||||
| Collaborators ICMJE | Fundação de Amparo à Pesquisa do Estado de São Paulo | ||||
| Investigators ICMJE |
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| Information Provided By | University of Sao Paulo | ||||
| Verification Date | December 2006 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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