Comparison of Pediatric Septic Shock Treatment With and Without Central Venous Oxygen Saturation Monitoring
Primary Purpose
Severe Sepsis, Septic Shock
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Central venous oxygen saturation continuous monitoring
Sponsored by
About this trial
This is an interventional treatment trial for Severe Sepsis focused on measuring Child, Septic shock, Resuscitation, Central venous oxygen saturation, Cardiac output, Goal-directed therapy
Eligibility Criteria
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.
Sites / Locations
- Instituto da Criança - HC-FMUSP
- Hospital Universitário - USP
Outcomes
Primary Outcome Measures
28-day mortality
Secondary Outcome Measures
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
Full Information
NCT ID
NCT00407823
First Posted
December 4, 2006
Last Updated
December 4, 2006
Sponsor
University of Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT00407823
Brief Title
Comparison of Pediatric Septic Shock Treatment With and Without Central Venous Oxygen Saturation Monitoring
Official Title
An Outcomes Comparison of ACCM/PALS Guidelines For Pediatric Septic Shock With and Without Central Venous Oxygen Saturation Monitoring
Study Type
Interventional
2. Study Status
Record Verification Date
December 2006
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Sepsis, Septic Shock
Keywords
Child, Septic shock, Resuscitation, Central venous oxygen saturation, Cardiac output, Goal-directed therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
268 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Central venous oxygen saturation continuous monitoring
Primary Outcome Measure Information:
Title
28-day mortality
Secondary Outcome Measure Information:
Title
Number of organ dysfunction
Title
Administered treatments
Title
Duration of cardiovascular agents therapy
Title
Duration of mechanical ventilation
Title
Length of Pediatric Intensive Care Unit stay
Title
Days free of cardiovascular agents
Title
Days free of mechanical ventilation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claudio F Oliveira, MD
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto da Criança - HC-FMUSP
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
05409-002
Country
Brazil
Facility Name
Hospital Universitário - USP
City
Sao Paulo
State/Province
SP
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
11794169
Citation
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.
Results Reference
result
PubMed Identifier
18369591
Citation
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.
Results Reference
derived
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Comparison of Pediatric Septic Shock Treatment With and Without Central Venous Oxygen Saturation Monitoring
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