Outcome Predictors in Patients With Severe Sepsis and Optimized Central Venous Oxygen Saturation
2 other identifiers
observational
90
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2009
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 24, 2011
CompletedFirst Posted
Study publicly available on registry
May 30, 2011
CompletedJune 21, 2011
May 1, 2011
1.7 years
May 24, 2011
June 20, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
In-Hospital Mortality
2 months
Severity of organ failure
1 week
Study Arms (1)
Patients with severe sepsis
Patients who are admitted to medical ICU with severe sepsis
Interventions
We perform a prospective observational study. All the treatment for the patients are determined by intended physicians.
Eligibility Criteria
Adult patients who are admitted to medical intensive care units due to severe sepsis or septic shock
You may qualify if:
- Adult patients who are admitted to medical intensive care units with severe sepsis or septic shock
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Taiwan University Hospitallead
- Far Eastern Memorial Hospitalcollaborator
Study Sites (2)
Far Eastern Memorial Hospital
Taipei, 100, Taiwan
National Taiwan University Hospital
Taipei, 100, Taiwan
Biospecimen
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.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chong-Jen Yu, MD, PhD
National Taiwan University Hospital
- PRINCIPAL INVESTIGATOR
Hou-Tai Chang, MD
Far Eastern Memorial Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 24, 2011
First Posted
May 30, 2011
Study Start
August 1, 2009
Primary Completion
May 1, 2011
Study Completion
May 1, 2011
Last Updated
June 21, 2011
Record last verified: 2011-05