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OpenTrials
Completed

NCT Number: NCT01013662

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

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

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Key information

Conditions

Septic Shock Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

glycemic control

Procedure

exogenous insulin

Primary outcomes

  1. establish a relationship between lipid metabolism alterations and glycemic control

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

Tight Glycemic Control and Sepsis Related Dyslipidemia

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Nov 16, 2009
Registry last updated
Aug 4, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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