Septic Shock, Severe Sepsis
Conditions
Keywords
Child, Septic shock, Resuscitation, Central venous oxygen saturation, Cardiac output, Goal-directed therapy
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.
Interventions
PROCEDURECentral venous oxygen saturation continuous monitoring
Sponsors
Fundação de Amparo à Pesquisa do Estado de São Paulo
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Months to 19 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 28-day mortality | — |
Secondary
| Measure | Time frame |
|---|---|
| Administered treatments | — |
| Duration of cardiovascular agents therapy | — |
| Duration of mechanical ventilation | — |
| Number of organ dysfunction | — |
| Days free of cardiovascular agents | — |
| Days free of mechanical ventilation | — |
| Length of Pediatric Intensive Care Unit stay | — |
Countries
Brazil
Outcome results
None listed