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

NCT ID: NCT01013662

Last Updated: 2011-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2007-07-31

Brief Summary

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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

Detailed Description

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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.

Conditions

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Septic Shock Sepsis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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glycemic control between 180 and 220 mg/dl

Group Type ACTIVE_COMPARATOR

glycemic control

Intervention Type PROCEDURE

exogenous insulin

glycemic control for levels between 80 and 110 mg/dl

Group Type ACTIVE_COMPARATOR

glycemic control

Intervention Type PROCEDURE

exogenous insulin

Interventions

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glycemic control

exogenous insulin

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Universidade de Sao Paulo

References

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Cappi SB, Noritomi DT, Velasco IT, Curi R, Loureiro TC, Soriano FG. Dyslipidemia: a prospective controlled randomized trial of intensive glycemic control in sepsis. Intensive Care Med. 2012 Apr;38(4):634-41. doi: 10.1007/s00134-011-2458-z. Epub 2012 Feb 2.

Reference Type DERIVED
PMID: 22297666 (View on PubMed)

Other Identifiers

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scap1501

Identifier Type: -

Identifier Source: org_study_id

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