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

University of Sao Paulo

Status: Completed

Conditions: Septic Shock; Sepsis

Treatments: Procedure: glycemic control

Study type: Interventional

Funder types: Other

Identifiers

NCT01013662

scap1501

Details and patient eligibility

About

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

Full 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.

Enrollment: 69 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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69 participants in 2 patient groups

glycemic control between 180 and 220 mg/dl

Active Comparator group

Treatment:

Procedure: glycemic control

glycemic control for levels between 80 and 110 mg/dl

Active Comparator group

Treatment:

Procedure: glycemic control