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

August 2, 2011 updated by: University of Sao Paulo

Tight Glycemic Control and Sepsis Related Dyslipidemia

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

69

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
establish a relationship between lipid metabolism alterations and glycemic control
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (Actual)

July 1, 2007

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

November 13, 2009

First Submitted That Met QC Criteria

November 13, 2009

First Posted (Estimate)

November 16, 2009

Study Record Updates

Last Update Posted (Estimate)

August 4, 2011

Last Update Submitted That Met QC Criteria

August 2, 2011

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • scap1501

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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