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Statin for Immunomudulation in Sepsis

Primary Purpose

Sepsis

Status

Unknown status

Phase

Phase 2

Locations

Brazil

Study Type

Interventional

Intervention

amido pill

atorvastatina

About this trial

This is an interventional treatment trial for Sepsis

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

clinical diagnosis of several sepsis or shock septic
no more than twenty four hours than diagnosis

Exclusion Criteria:

use of statins in the last thirty days
unequivocal indication for statin treatment
active treatment with imunosuppressors drugs
High risk of rhabdomyolysis: multiple trauma, crush injuries, baseline creatinine kinase > three times upper limit of normal
diagnosis of AIDS
unable to receive enteral medications
pregnancy
expected survival of less than 48 hours

Sites / Locations

HCPA - Clinical Hospital fo Porto AlegreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

amido pill

atorvastatina

Arm Description

atrovastatina 80 mg/d by mouth for 10 days

Outcomes

Primary Outcome Measures

action in inflammmatory biologic makers

valuation of flow-mediated vasodilation of the brachial artery

Secondary Outcome Measures

mortality

time of permanence in intensive care unity

time of permanence in mechanical ventilation

Full Information

NCT ID

NCT00452608

First Posted

March 26, 2007

Last Updated

June 25, 2009

Sponsor

Hospital de Clinicas de Porto Alegre

1. Study Identification

Unique Protocol Identification Number

NCT00452608

Brief Title

Statin for Immunomudulation in Sepsis

Official Title

Use of Statins in Modulation of Inflammatory Answer in Septic Patients

Study Type

Interventional

2. Study Status

Record Verification Date

June 2009

Overall Recruitment Status

Unknown status

Study Start Date

December 2006 (undefined)

Primary Completion Date

December 2009 (Anticipated)

Study Completion Date

December 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Hospital de Clinicas de Porto Alegre

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to determine whether atorvastatin can improve the inflammatory answer in the septic patients

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sepsis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

amido pill

Arm Type

Placebo Comparator

Arm Title

atorvastatina

Arm Type

Experimental

Arm Description

atrovastatina 80 mg/d by mouth for 10 days

Intervention Type

Drug

Intervention Name(s)

amido pill

Intervention Description

one pill of amido/d by mouth for 10 days

Intervention Type

Drug

Intervention Name(s)

atorvastatina

Intervention Description

atorvastatina 80 mg/day by mouth for 10 days

Primary Outcome Measure Information:

Title

action in inflammmatory biologic makers

Time Frame

24h; 72h; 10 days

Title

valuation of flow-mediated vasodilation of the brachial artery

Time Frame

24h; 72; 10 days

Secondary Outcome Measure Information:

Title

mortality

Time Frame

at end

Title

time of permanence in intensive care unity

Time Frame

at end

Title

time of permanence in mechanical ventilation

Time Frame

at end

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: clinical diagnosis of several sepsis or shock septic no more than twenty four hours than diagnosis Exclusion Criteria: use of statins in the last thirty days unequivocal indication for statin treatment active treatment with imunosuppressors drugs High risk of rhabdomyolysis: multiple trauma, crush injuries, baseline creatinine kinase > three times upper limit of normal diagnosis of AIDS unable to receive enteral medications pregnancy expected survival of less than 48 hours

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Karen F Prado, investigator

Phone

051-98088153

Ext

karen@portoweb.com.br

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nadine Clausell

Organizational Affiliation

Federal University of Rio Grande do Sul - Brazil

Official's Role

Principal Investigator

Facility Information:

Facility Name

HCPA - Clinical Hospital fo Porto Alegre

City

Porto Alegre

State/Province

Rio Grande do Sul

ZIP/Postal Code

90035-903

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Karen F Prado

12. IPD Sharing Statement

Learn more about this trial

Statin for Immunomudulation in Sepsis

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