NCT00452608

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P25-P50 for phase_2 sepsis

Timeline
Completed

Started Dec 2006

Typical duration for phase_2 sepsis

Geographic Reach
1 country

1 active site

Status
unknown

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

December 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 27, 2007

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

June 26, 2009

Status Verified

June 1, 2009

Enrollment Period

3 years

First QC Date

March 26, 2007

Last Update Submit

June 25, 2009

Conditions

Sepsis

Outcome Measures

Primary Outcomes (2)

  • action in inflammmatory biologic makers

    24h; 72h; 10 days

  • valuation of flow-mediated vasodilation of the brachial artery

    24h; 72; 10 days

Secondary Outcomes (3)

  • mortality

    at end

  • time of permanence in intensive care unity

    at end

  • time of permanence in mechanical ventilation

    at end

Study Arms (2)

amido pill

PLACEBO COMPARATOR
Drug: amido pill

atorvastatina

EXPERIMENTAL

atrovastatina 80 mg/d by mouth for 10 days

Drug: atorvastatina

Interventions

amido pillDRUG

one pill of amido/d by mouth for 10 days

amido pill
atorvastatinaDRUG

atorvastatina 80 mg/day by mouth for 10 days

atorvastatina

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HCPA - Clinical Hospital fo Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

RECRUITING

MeSH Terms

Conditions

Sepsis

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Nadine Clausell

    Federal University of Rio Grande do Sul - Brazil

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Karen F Prado, investigator

CONTACT

051-98088153karen@portoweb.com.br

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 26, 2007

First Posted

March 27, 2007

Study Start

December 1, 2006

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

June 26, 2009

Record last verified: 2009-06

Locations

BR(1)