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

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ClinicalTrials.gov Identifier: NCT01013662
Recruitment Status : Completed
First Posted : November 16, 2009
Last Update Posted : August 4, 2011
Information provided by:
University of Sao Paulo

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

Condition or disease Intervention/treatment
Septic Shock Sepsis Procedure: glycemic control

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Tight Glycemic Control and Sepsis Related Dyslipidemia
Study Start Date : January 2005
Primary Completion Date : July 2007
Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis Shock
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: glycemic control between 180 and 220 mg/dl Procedure: glycemic control
exogenous insulin
Active Comparator: glycemic control for levels between 80 and 110 mg/dl Procedure: glycemic control
exogenous insulin

Primary Outcome Measures :
  1. establish a relationship between lipid metabolism alterations and glycemic control [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Francisco Garcia Soriano, Universidade de Sao Paulo
ClinicalTrials.gov Identifier: NCT01013662     History of Changes
Other Study ID Numbers: scap1501
First Posted: November 16, 2009    Key Record Dates
Last Update Posted: August 4, 2011
Last Verified: November 2009

Keywords provided by University of Sao Paulo:
septic shock
glycemic control
lipid metabolism
septic patients

Additional relevant MeSH terms:
Shock, Septic
Systemic Inflammatory Response Syndrome
Pathologic Processes