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

University of Sao Paulo

Status

Completed

Conditions

Severe Sepsis

Septic Shock

Treatments

Procedure: Central venous oxygen saturation continuous monitoring

Study type

Interventional

Funder types

Other

Identifiers

NCT00407823

2004/07949-7

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

1 month to 19 years old

Volunteers

No Healthy Volunteers

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.