Lipid Profile in Patients With Severe Sepsis or Septic Sh... | NCT01013662

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

NCT01013662

Sponsor

University of Sao Paulo

Status

Completed

Last Update Posted

Aug 4, 2011Estimated

Enrollment

69Actual

Phase

Not Applicable

Conditions

Septic Shock
Sepsis

Interventions

glycemic control

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2005

Primary Completion Date

Jul 2007Actual

Completion Date

Jul 2007Actual

First Submitted Date

Nov 13, 2009

First Submission Date that Met QC Criteria

Nov 13, 2009

First Posted Date

Nov 16, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 2, 2011

Last Update Posted Date

Aug 4, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

69Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
glycemic control	Procedure	exogenous insulin	glycemic control between 180 and 220 mg/dl glycemic control for levels between 80 and 110 mg/dl

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
establish a relationship between lipid metabolism alterations and glycemic control		2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22297666	Derived	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.

ID	Term
D012772	Shock, Septic
D018805	Sepsis

ID	Term
D007239	Infections
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation
D010335	Pathologic Processes