SepsisPhase 2NCT00452608
Statin for Immunomudulation in Sepsis
A Phase 2 study testing amido pill and atorvastatina in people with Sepsis, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
The purpose of this study is to determine whether atorvastatin can improve the inflammatory answer in the septic patients Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- amido pill and atorvastatina
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteBrazil
- Study dates
- Dec 2006to Dec 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- clinical diagnosis of several sepsis or shock septic
- no more than twenty four hours than diagnosis
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
HCPA - Clinical Hospital fo Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
Karen F Prado
About this study
Official title: Use of Statins in Modulation of Inflammatory Answer in Septic Patients
The purpose of this study is to determine whether atorvastatin can improve the inflammatory answer in the septic patients
- Conditions
- Sepsis
- Being tested
- amido pill, atorvastatina
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amido pillDrug
one pill of amido/d by mouth for 10 days
atorvastatinaDrug
atorvastatina 80 mg/day by mouth for 10 days
| Study group | Role | What they receive |
|---|---|---|
| amido pill | Placebo comparator | Not described Receives: Drug: amido pill |
| atorvastatina | Experimental | atrovastatina 80 mg/d by mouth for 10 days Receives: Drug: atorvastatina |
What is being measured
The primary outcome is the main question the study is designed to answer.
action in inflammmatory biologic makers
Measured: 24h; 72h; 10 days
valuation of flow-mediated vasodilation of the brachial artery
Measured: 24h; 72; 10 days
Secondary outcomes (3)
mortality
Measured: at end
time of permanence in intensive care unity
Measured: at end
time of permanence in mechanical ventilation
Measured: at end
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2007 (estimated)
- Study startDec 2006
- Primary completionDec 2009 (estimated)
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Investigators
- Nadine Clausell, Principal investigator, Federal University of Rio Grande do Sul - Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00452608
- Sponsor's protocol ID
- 05589
- Status last verified
- Jun 2009
- First submitted
- 26 Mar 2007
- Last updated
- 26 Jun 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Statins in Modulation of Inflammatory Answer in Septic Patients
- ClinicalTrials.gov ID
- NCT00452608
- Acronym / sponsor ID
- 05589
- Conditions
- Sepsis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- Dec 2006
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 27 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether atorvastatin can improve the inflammatory answer in the septic patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| amido pill | Placebo comparator | Drug: amido pill |
| atorvastatina | Experimental | Drug: atorvastatinaatrovastatina 80 mg/d by mouth for 10 days |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- clinical diagnosis of several sepsis or shock septic
- no more than twenty four hours than diagnosis
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| amido pillone pill of amido/d by mouth for 10 days | Drug | amido pill |
| atorvastatinaatorvastatina 80 mg/day by mouth for 10 days | Drug | atorvastatina |
Primary outcome
action in inflammmatory biologic makers
Time frame: 24h; 72h; 10 days
valuation of flow-mediated vasodilation of the brachial artery
Time frame: 24h; 72; 10 days
3 secondary outcomes
mortality
Time frame: at end
time of permanence in intensive care unity
Time frame: at end
time of permanence in mechanical ventilation
Time frame: at end
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nadine Clausell principal investigator
Federal University of Rio Grande do Sul - Brazil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing amido pill and atorvastatina in people with Sepsis, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karen F Prado, investigator (051-98088153 ext. 55, karen@portoweb.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
action in inflammmatory biologic makers (time frame: 24h; 72h; 10 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2009.