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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Severe Sepsis, Septic Shock

Intervention / Treatment
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* Procedure: Central venous oxygen saturation continuous monitoring


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Central venous oxygen saturation continuous monitoring|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 28-day mortality |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Child, Septic shock, Resuscitation, Central venous oxygen saturation, Cardiac output, Goal-directed therapy