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

This study has been completed.
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT00407823
First received: December 4, 2006
Last updated: NA
Last verified: December 2006
History: No changes posted

December 4, 2006
December 4, 2006
January 2004
Not Provided
28-day mortality
Same as current
No Changes Posted
  • Number of organ dysfunction
  • Administered treatments
  • Duration of cardiovascular agents therapy
  • Duration of mechanical ventilation
  • Length of Pediatric Intensive Care Unit stay
  • Days free of cardiovascular agents
  • Days free of mechanical ventilation
Same as current
Not Provided
Not Provided
 
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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Severe Sepsis
  • Septic Shock
Procedure: Central venous oxygen saturation continuous monitoring
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
268
August 2005
Not Provided

Inclusion Criteria:

  • patients with severe sepsis or fluid-refractory septic shock that had not responded after 40 mL/kg of any resuscitation fluid or that required cardiovascular agents at any time during resuscitation

Exclusion Criteria:

  • refusal to sign the written informed consent
  • age less than 1 month or older than 19 years
  • uncorrected cyanotic heart disease
  • patients receiving exclusive palliative care
  • patients that arrived from other hospitals more than 6 hours after the diagnosis of severe sepsis or septic shock.
Both
1 Month to 19 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00407823
2004/07949-7
Not Provided
Not Provided
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Principal Investigator: Claudio F Oliveira, MD University of Sao Paulo
University of Sao Paulo
December 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP