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
  Purpose

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.


Condition Intervention
Severe Sepsis
Septic Shock
Procedure: Central venous oxygen saturation continuous monitoring

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Outcomes Comparison of ACCM/PALS Guidelines For Pediatric Septic Shock With and Without Central Venous Oxygen Saturation Monitoring

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

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

Estimated Enrollment: 268
Study Start Date: January 2004
Estimated Study Completion Date: August 2005
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.

  Eligibility

Ages Eligible for Study:   1 Month to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00407823

Locations
Brazil
Instituto da Criança - HC-FMUSP
Sao Paulo, SP, Brazil, 05409-002
Hospital Universitário - USP
Sao Paulo, SP, Brazil
Sponsors and Collaborators
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Principal Investigator: Claudio F Oliveira, MD University of Sao Paulo
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00407823     History of Changes
Other Study ID Numbers: 2004/07949-7
Study First Received: December 4, 2006
Last Updated: December 4, 2006
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
Child
Septic shock
Resuscitation
Central venous oxygen saturation
Cardiac output
Goal-directed therapy

Additional relevant MeSH terms:
Shock
Shock, Septic
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation

ClinicalTrials.gov processed this record on October 19, 2014