Outcome Predictors in Patients With Severe Sepsis and Optimized Central Venous Oxygen Saturation
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Outcome Predictors in Patients With Severe Sepsis and Optimized Central Venous Oxygen Saturation|
- 28-day Mortality [ Time Frame: 28 days ] [ Designated as safety issue: No ]Record 28-day all-cause mortality in each population (low ScvO2, high ScvO2 and low serum lactate, high ScvO2 and high serum lactate)
- In-Hospital Mortality [ Time Frame: 2 months ] [ Designated as safety issue: No ]Participants will be followed for the duration of hospital stay, an expected average of 2 months
- Severity of organ failure [ Time Frame: 1 week ] [ Designated as safety issue: No ]To evaluate the development of ARDS/ALI, AKI, and the record the SOFA score
Biospecimen Retention: Samples Without DNA
For each patient enrolled, 10mL blood is collected in EDTA-coated tube, which will be used for plasma separation and for peripheral blood mononuclear cell collection.
|Study Start Date:||August 2009|
|Study Completion Date:||May 2011|
|Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
Patients with severe sepsis
Patients who are admitted to medical ICU with severe sepsis
Other: Determined by intended physician
We perform a prospective observational study. All the treatment for the patients are determined by intended physicians.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01362829
|Far Eastern Memorial Hospital|
|Taipei, Taiwan, 100|
|National Taiwan University Hospital|
|Taipei, Taiwan, 100|
|Principal Investigator:||Chong-Jen Yu, MD, PhD||National Taiwan University Hospital|
|Principal Investigator:||Hou-Tai Chang, MD||Far Eastern Memorial Hospital|