NCT00407823

Comparison of Pediatric Septic Shock Treatment With and Without Central Venous Oxygen Saturation Monitoring

An Outcomes Comparison of ACCM/PALS Guidelines For Pediatric Septic Shock With and Without Central Venous Oxygen Saturation Monitoring

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 268 (planned)
• Sponsor: University of Sao Paulo · Academic / Other
• Sex: All
• Age: 1 Month – 19 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Severe Sepsis
• Septic Shock

Interventions

Type	Name	Description
PROCEDURE	Central venous oxygen saturation continuous monitoring

Timeline

• Start date: 2004-01-01
• Completion: 2005-08-01
• First posted: 2006-12-05
• Last updated: 2006-12-05

Locations

2 sites across 1 country: Brazil