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

Sepsis Clinical Trial

Official title:

Tight Glycemic Control and Sepsis Related Dyslipidemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01013662
• Other study ID #: scap1501
• Status: Completed
• Phase: N/A
• First received: November 13, 2009
• Last updated: August 2, 2011
• Start date: January 2005
• Est. completion date: July 2007

Study information

• Verified date: November 2009
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Sepsis
• Septic Shock
• Shock
• Shock, Septic

Intervention

Procedure:
• glycemic control
exogenous insulin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	establish a relationship between lipid metabolism alterations and glycemic control		2 years	Yes