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Extravascular Lung Water Index in Severe Sepsis (EVLI in sepsis)

Primary Purpose

Severe Sepsis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
EVLI was determinated by PiCCO plus system.
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Severe Sepsis focused on measuring severe sepsis, intensive care units

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

Inclusion Criteria:

  • All enrolled patients were recruited consecutively on the day of MICU admission and within 24 hours of the diagnosis of severe sepsis.

Exclusion Criteria:

  • Pregnancy,
  • Age less than 18 years old, and
  • Uncontrolled malignancy.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    With and without MODS developement

    Arm Description

    EVLI was determinated by PiCCO plus system.

    Outcomes

    Primary Outcome Measures

    Developement of MODS (multiorgan dysfunction syndrome) and mortality

    Secondary Outcome Measures

    Full Information

    First Posted
    September 27, 2009
    Last Updated
    September 28, 2009
    Sponsor
    Chang Gung Memorial Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00986271
    Brief Title
    Extravascular Lung Water Index in Severe Sepsis
    Acronym
    EVLI in sepsis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Chang Gung Memorial Hospital

    4. Oversight

    5. Study Description

    Brief Summary
    To investigate whether extravascular lung water index (EVLI) is an independent predictor for multiorgan dysfunction syndrome (MODS) in patients with severe sepsis and to determine if increased EVLI may serve as an predictor for MODS and mortality in those patients.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Severe Sepsis
    Keywords
    severe sepsis, intensive care units

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Enrollment
    67 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    With and without MODS developement
    Arm Type
    Other
    Arm Description
    EVLI was determinated by PiCCO plus system.
    Intervention Type
    Procedure
    Intervention Name(s)
    EVLI was determinated by PiCCO plus system.
    Primary Outcome Measure Information:
    Title
    Developement of MODS (multiorgan dysfunction syndrome) and mortality

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Eligibility Criteria
    Inclusion Criteria: All enrolled patients were recruited consecutively on the day of MICU admission and within 24 hours of the diagnosis of severe sepsis. Exclusion Criteria: Pregnancy, Age less than 18 years old, and Uncontrolled malignancy.

    12. IPD Sharing Statement

    Learn more about this trial

    Extravascular Lung Water Index in Severe Sepsis

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