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 Overview

• Status: Completed
• Conditions: Sepsis
• Intervention / Treatment: Other: Determined by intended physician

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.

• Study Type: Observational
• Enrollment (Actual): 90

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital
  • Taipei, Taiwan, 100
    • Far Eastern Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
28-day Mortality	Record 28-day all-cause mortality in each population (low ScvO2, high ScvO2 and low serum lactate, high ScvO2 and high serum lactate)	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
In-Hospital Mortality	Participants will be followed for the duration of hospital stay, an expected average of 2 months	2 months
Severity of organ failure	To evaluate the development of ARDS/ALI, AKI, and the record the SOFA score	1 week

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Collaborators: Far Eastern Memorial Hospital
• Investigators: Principal Investigator: Chong-Jen Yu, MD, PhD, National Taiwan University Hospital; Principal Investigator: Hou-Tai Chang, MD, Far Eastern Memorial Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: May 24, 2011
• First Submitted That Met QC Criteria: May 27, 2011
• First Posted (Estimate): May 30, 2011

Study Record Updates

• Last Update Posted (Estimate): June 21, 2011
• Last Update Submitted That Met QC Criteria: June 20, 2011
• Last Verified: May 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia
• Other Study ID Numbers: 200907064R; 098014-3 (Other Identifier: Far Eastern Memorial Hospital)