NCT01013662

Brief 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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2005

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

November 13, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 16, 2009

Completed
Last Updated

August 4, 2011

Status Verified

November 1, 2009

Enrollment Period

2.5 years

First QC Date

November 13, 2009

Last Update Submit

August 2, 2011

Conditions

Septic ShockSepsis

Keywords

septic shockglycemic controliculipid metabolismseptic patients

Outcome Measures

Primary Outcomes (1)

  • establish a relationship between lipid metabolism alterations and glycemic control

    2 years

Study Arms (2)

glycemic control between 180 and 220 mg/dl

ACTIVE COMPARATOR
Procedure: glycemic control

glycemic control for levels between 80 and 110 mg/dl

ACTIVE COMPARATOR
Procedure: glycemic control

Interventions

glycemic controlPROCEDURE

exogenous insulin

glycemic control between 180 and 220 mg/dlglycemic control for levels between 80 and 110 mg/dl

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • all patients aged between 18 and 80 years old
  • with the diagnostic of septic shock or severe sepsis

You may not qualify if:

  • pregnants,
  • previous diagnosis of any cancer,
  • diagnosis of leptospirosis,
  • diagnosis of aids.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 22297666DERIVED

MeSH Terms

Conditions

Shock, SepticSepsis

Interventions

Glycemic Control

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 13, 2009

First Posted

November 16, 2009

Study Start

January 1, 2005

Primary Completion

July 1, 2007

Study Completion

July 1, 2007

Last Updated

August 4, 2011

Record last verified: 2009-11