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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00407823
Recruitment Status : Completed
First Posted : December 5, 2006
Last Update Posted : December 5, 2006
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
University of Sao Paulo

Study Description
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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.

Condition or disease Intervention/treatment Phase
Severe Sepsis Septic Shock Procedure: Central venous oxygen saturation continuous monitoring Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 268 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : January 2004
Study Completion Date : August 2005

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. 28-day mortality

Secondary Outcome Measures :
  1. Number of organ dysfunction
  2. Administered treatments
  3. Duration of cardiovascular agents therapy
  4. Duration of mechanical ventilation
  5. Length of Pediatric Intensive Care Unit stay
  6. Days free of cardiovascular agents
  7. Days free of mechanical ventilation

Eligibility Criteria
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Ages Eligible for Study:   1 Month to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
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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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00407823


Locations
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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
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Principal Investigator: Claudio F Oliveira, MD University of Sao Paulo
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00407823    
Other Study ID Numbers: 2004/07949-7
First Posted: December 5, 2006    Key Record Dates
Last Update Posted: December 5, 2006
Last Verified: December 2006
Keywords provided by University of Sao Paulo:
Child
Septic shock
Resuscitation
 Central venous oxygen saturation
Cardiac output
Goal-directed therapy
Additional relevant MeSH terms:
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Shock, Septic
Sepsis
Shock
Pathologic Processes
 Infections
Systemic Inflammatory Response Syndrome
Inflammation