Statin for Immunomudulation in Sepsis | NCT00452608

Studies
Statin for Immunomudulation in Sepsis

NCT00452608

Sponsor

Hospital de Clinicas de Porto Alegre

Status

Unknown status

Last Update Posted

Jun 26, 2009Estimated

Enrollment

80Estimated

Phase

Phase 2

Conditions

Sepsis

Interventions

amido pill
atorvastatina

Countries

Brazil

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

Jun 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2006

Primary Completion Date

Dec 2009Estimated

Completion Date

Dec 2009Estimated

First Submitted Date

Mar 26, 2007

First Submission Date that Met QC Criteria

Mar 26, 2007

First Posted Date

Mar 27, 2007Estimated

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

Jun 25, 2009

Last Update Posted Date

Jun 26, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

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

Detailed Description

Not provided

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

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
amido pill	Placebo Comparator		Drug: amido pill
atorvastatina	Experimental	atrovastatina 80 mg/d by mouth for 10 days	Drug: atorvastatina

Interventions

Name	Type	Description	Arm Group Labels	Other Names
amido pill	Drug	one pill of amido/d by mouth for 10 days	amido pill

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
action in inflammmatory biologic makers		24h; 72h; 10 days
valuation of flow-mediated vasodilation of the brachial artery		24h; 72; 10 days

Secondary Outcomes

Measure	Description	Time Frame
mortality		at end
time of permanence in intensive care unity		at end
time of permanence in mechanical ventilation

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Karen F Prado, investigator	Contact	051-98088153	55	karen@portoweb.com.br

Overall Officials

Name	Affiliation	Role
Nadine Clausell	Federal University of Rio Grande do Sul - Brazil	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
HCPA - Clinical Hospital fo Porto Alegre	Recruiting	Porto Alegre	Rio Grande do Sul	90035-903	Brazil

Condition Browse Module

MeSH Terms

ID	Term
D018805	Sepsis

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069059	Atorvastatin

Ancestor Terms

ID	Term
D011758	Pyrroles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided