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

Septic Shock Clinical Trial

Official title:

An Outcomes Comparison of ACCM/PALS Guidelines For Pediatric Septic Shock With and Without Central Venous Oxygen Saturation Monitoring

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00407823
• Other study ID #: 2004/07949-7
• Status: Completed
• Phase: N/A
• First received: December 4, 2006
• Last updated: December 4, 2006
• Start date: January 2004
• Est. completion date: August 2005

Study information

• Verified date: December 2006
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 268
• Est. completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 19 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Septic Shock
• Severe Sepsis
• Shock
• Shock, Septic

Intervention

Procedure:
• Central venous oxygen saturation continuous monitoring

Locations

Country	Name	City	State
Brazil	Hospital Universitário - USP	Sao Paulo	SP
Brazil	Instituto da Criança - HC-FMUSP	Sao Paulo	SP

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

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):13 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	28-day mortality
Secondary	Number of organ dysfunction
Secondary	Administered treatments
Secondary	Duration of cardiovascular agents therapy
Secondary	Duration of mechanical ventilation
Secondary	Length of Pediatric Intensive Care Unit stay
Secondary	Days free of cardiovascular agents
Secondary	Days free of mechanical ventilation