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Lipid Profile in Patients With Severe Sepsis or Septic Shock Under Strict or Liberal Glycemic Control

Primary Purpose

Septic Shock, Sepsis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
glycemic control
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Septic Shock focused on measuring septic shock, glycemic control, icu, lipid metabolism, septic patients

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • all patients aged between 18 and 80 years old
  • with the diagnostic of septic shock or severe sepsis

Exclusion Criteria:

  • pregnants,
  • previous diagnosis of any cancer,
  • diagnosis of leptospirosis,
  • diagnosis of aids.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    glycemic control between 180 and 220 mg/dl

    glycemic control for levels between 80 and 110 mg/dl

    Arm Description

    Outcomes

    Primary Outcome Measures

    establish a relationship between lipid metabolism alterations and glycemic control

    Secondary Outcome Measures

    Full Information

    First Posted
    November 13, 2009
    Last Updated
    August 2, 2011
    Sponsor
    University of Sao Paulo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01013662
    Brief Title
    Lipid Profile in Patients With Severe Sepsis or Septic Shock Under Strict or Liberal Glycemic Control
    Official Title
    Tight Glycemic Control and Sepsis Related Dyslipidemia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2005 (undefined)
    Primary Completion Date
    July 2007 (Actual)
    Study Completion Date
    July 2007 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University of Sao Paulo

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Study of the lipid metabolism under glycemic control in septic patients who got an university 14 bed ICU. Hypothesis: establish a relationship between lipid metabolism alterations and glycemic control or infusion of exogenous insulin
    Detailed Description
    The investigators enrolled 69 consecutive patients with severe sepsis or septic shock and divided them in two different groups after randomization with sealed envelopes. One group called intensive glycemic control with glycemic levels been between 80 to 110 mg/dl with exogenous insulin. The other group called conventional glycemic control with glycemic levels been between 180 and 220 mg/dl. Blood samples were collected at 0, 12, 24, 48 and 72 hours to measure HDL, LDL, Total cholesterol, free fatty acids and oxidized LDL. Clinical data as creatinine, P/F ratio, bilirubins, platelets, lactate, arterial blood gasometry were either monitored.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Septic Shock, Sepsis
    Keywords
    septic shock, glycemic control, icu, lipid metabolism, septic patients

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    69 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    glycemic control between 180 and 220 mg/dl
    Arm Type
    Active Comparator
    Arm Title
    glycemic control for levels between 80 and 110 mg/dl
    Arm Type
    Active Comparator
    Intervention Type
    Procedure
    Intervention Name(s)
    glycemic control
    Intervention Description
    exogenous insulin
    Primary Outcome Measure Information:
    Title
    establish a relationship between lipid metabolism alterations and glycemic control
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: all patients aged between 18 and 80 years old with the diagnostic of septic shock or severe sepsis Exclusion Criteria: pregnants, previous diagnosis of any cancer, diagnosis of leptospirosis, diagnosis of aids.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    22297666
    Citation
    Cappi SB, Noritomi DT, Velasco IT, Curi R, Loureiro TC, Soriano FG. Dyslipidemia: a prospective controlled randomized trial of intensive glycemic control in sepsis. Intensive Care Med. 2012 Apr;38(4):634-41. doi: 10.1007/s00134-011-2458-z. Epub 2012 Feb 2.
    Results Reference
    derived

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    Lipid Profile in Patients With Severe Sepsis or Septic Shock Under Strict or Liberal Glycemic Control

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