Clinical trial NCT00407823: 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
Overall status: COMPLETED
Phase: NA
Conditions: Severe Sepsis
Septic Shock
Keywords: Child
Septic shock
Resuscitation
Central venous oxygen saturation
Cardiac output
Goal-directed therapy
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2006-12-05
Enrollment: 268
Sex: ALL
Minimum age (years): 1
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 28-day mortality
Secondary outcomes:
measure: Number of organ dysfunction
measure: Administered treatments
measure: Duration of cardiovascular agents therapy
measure: Duration of mechanical ventilation
measure: Length of Pediatric Intensive Care Unit stay
measure: Days free of cardiovascular agents
measure: Days free of mechanical ventilation
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Instituto da Criança - HC-FMUSP
state: SP
city: Sao Paulo
country: Brazil
facility: Hospital Universitário - USP
state: SP
Study officials:
affiliation: University of Sao Paulo
name: Claudio F Oliveira, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.