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

This study has been completed.
Sponsor:
Collaborator:
Far Eastern Memorial Hospital
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01362829
First received: May 24, 2011
Last updated: June 20, 2011
Last verified: May 2011
History of Changes
  Purpose

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.


Condition Intervention
Sepsis
 Other: Determined by intended physician

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Outcome Predictors in Patients With Severe Sepsis and Optimized Central Venous Oxygen Saturation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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.


Enrollment: 90
Study Start Date: August 2009
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01362829

Locations
Taiwan
National Taiwan University Hospital
Taipei, Taiwan, 100
Far Eastern Memorial Hospital
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
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
  More Information

No publications provided

Responsible Party: Yu, Chong-Jen/MD, PhD, National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01362829     History of Changes
Other Study ID Numbers: 200907064R, 098014-3
Study First Received: May 24, 2011
Last Updated: June 20, 2011
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Sepsis
Toxemia
Infection
 Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on May 21, 2013