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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

Tracking Information
First Submitted Date  ICMJE December 4, 2006
First Posted Date  ICMJE December 5, 2006
Last Update Posted Date December 5, 2006
Study Start Date  ICMJE January 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: December 4, 2006)
28-day mortality
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 4, 2006)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Pediatric Septic Shock Treatment With and Without Central Venous Oxygen Saturation Monitoring
Official Title  ICMJE An Outcomes Comparison of ACCM/PALS Guidelines For Pediatric Septic Shock With and Without Central Venous Oxygen Saturation Monitoring
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Severe Sepsis
  • Septic Shock
Intervention  ICMJE Procedure: Central venous oxygen saturation continuous monitoring
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: December 4, 2006)
268
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE August 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Month to 19 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00407823
Other Study ID Numbers  ICMJE 2004/07949-7
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE University of Sao Paulo
Collaborators  ICMJE Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators  ICMJE
Principal Investigator: Claudio F Oliveira, MD University of Sao Paulo
PRS Account University of Sao Paulo
Verification Date December 2006

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