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

This study has been completed.
Sponsor:
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01013662
First received: November 13, 2009
Last updated: August 2, 2011
Last verified: November 2009
  Purpose

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 Intervention
Septic Shock
Sepsis
Procedure: glycemic control

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Tight Glycemic Control and Sepsis Related Dyslipidemia

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • establish a relationship between lipid metabolism alterations and glycemic control [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Enrollment: 69
Study Start Date: January 2005
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided by University of Sao Paulo

Additional 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
Study First Received: November 13, 2009
Last Updated: August 2, 2011
Health Authority: Brazil: National Committee of Ethics in Research

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

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

ClinicalTrials.gov processed this record on July 28, 2014