Clinical trial NCT01362829: Outcome Predictors in Patients With Severe Sepsis and Optimized Central Venous Oxygen Saturation
Official title: Outcome Predictors in Patients With Severe Sepsis and Optimized Central Venous Oxygen Saturation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: Far Eastern Memorial Hospital
First posted: 2011-05-30
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients who are admitted to medical intensive care units due to severe sepsis or septic shock

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.

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
  * febrile neutropenia
  * treatment with immunosuppressive agents before admission
  * advanced malignancy and poor pre-admission performance status
  * with inevitable short-term mortality or morbidity
  * HIV infection
  * refusal of consent

Primary outcomes:
measure: 28-day Mortality
timeFrame: 28 days
Secondary outcomes:
measure: In-Hospital Mortality
timeFrame: 2 months
measure: Severity of organ failure
timeFrame: 1 week
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Far Eastern Memorial Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Chong-Jen Yu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Far Eastern Memorial Hospital
name: Hou-Tai Chang, MD
role: PRINCIPAL_INVESTIGATOR
References: