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Clinical Trials/NCT01362829
NCT01362829
Completed
Not Applicable

Outcome Predictors in Patients With Severe Sepsis and Optimized Central Venous Oxygen Saturation

National Taiwan University Hospital2 sites in 1 country90 target enrollmentAugust 2009
ConditionsSepsis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sepsis
Sponsor
National Taiwan University Hospital
Enrollment
90
Locations
2
Primary Endpoint
28-day Mortality
Status
Completed
Last Updated
14 years ago

Overview

Brief Summary

The investigators perform a prospective observation study to search for the outcome predictors (ScvO2 and lactate) in patients with severe sepsis after admission to ICU.

Detailed Description

Early goal-directed therapy in patients with severe sepsis or septic shock was found to provide survival benefit.It was thought that early optimization of ScvO2 within 6 hours in emergency department brought survival benefit to patients of septic shock or severe sepsis.On the other hand, early lactate clearance is associated with improved outcome in patients with severe sepsis or septic shock. In patients with severe sepsis and septic shock, those with low lactate clearance had poor prognosis, despite optimization of ScvO2. It is unknown if ScvO2 could still guide hemodynamic resuscitation after admission into ICU. The investigators perform a prospective observation study to see the correlation between ScvO2 and clinical outcome (including organ failure, disease severity, and survival) and the correlation between lactate and clinical outcome. Furthermore, if ScvO2 \>= 70% is still of prognostic significance in ICU, we will investigate the outcome in patients with high ScvO2 and high serum lactate levels, and to evaluate the clinical features of this patient population.

Registry
clinicaltrials.gov
Start Date
August 2009
End Date
May 2011
Last Updated
14 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Adult patients who are admitted to medical intensive care units with severe sepsis or septic shock

Exclusion Criteria

  • Patients would be excluded if they have any one of the exclusion criteria, \*including pregnancy
  • presence of acute cerebral vascular attack
  • acute cardiogenic lung edema
  • status asthmatics
  • cardiac dysrhythmia as the primary diagnosis
  • massive gastrointestinal bleeding
  • epileptics
  • drug overdose
  • requirement of immediate surgery
  • hematologic malignancies

Outcomes

Primary Outcomes

28-day Mortality

Time Frame: 28 days

Record 28-day all-cause mortality in each population (low ScvO2, high ScvO2 and low serum lactate, high ScvO2 and high serum lactate)

Secondary Outcomes

  • Severity of organ failure(1 week)
  • In-Hospital Mortality(2 months)

Study Sites (2)

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