SepsisPhase 2NCT00357123
Effect of Rosuvastatin in Abdominal Sepsis
A Phase 2 study testing Rosuvastatin in people with Sepsis, run by Universidad Autonoma de San Luis Potosí at 1 site in Mexico.
Trial summary
The purpose of this study is to determine whether rosuvastatin is effective as a coadjuvant drug in the integral management of abdominal sepsis acknowledged by surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sepsis
- What is being tested?
- Rosuvastatin
- How many people
- 60 participants
- Where
- 1 siteMexico
- Study dates
- Aug 2006to Sep 2011
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Man or women > 18 and < 80 years old with abdominal sepsis, confirmed diagnosis by surgery of broad peritonitis before 48 hours in progression
- Injury by steel or firearm with contaminated abdominal cavity
- APACHE II major or equal than 8
- Acceptance to be included
Who cannot join
- Ingestion of: fibrates, niacin, cyclosporin, azoles, macrolides, inhibitors of protease, nefazodone, verapamil, diltiazem, amiodarone
- Hypovolemic shock III and IV after get surgery
- Cardio-respiratory failure pre or trans surgery
- Allergy to used drug
- Use previous of statin
- Hepatopathy or myopathy and(or) history, hepatic failure (Child B y C)
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- Management in other Hospital
- Pregnancy
- Thoracic injury, head injury (moderate and severe), multiple fractures or with bone exposition, rectal injury
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Hospital Central "Dr. Ignacio Morones Prieto
San Luis Potosí City, San Luis Potosí, 78240
Lorenzo Guevara-Torres, MD
Jorge H Tapia-Perez, MD
About this study
Official title: Use of Rosuvastatin in Integral Management of Abdominal Sepsis
The purpose of this study is to determine whether rosuvastatin is effective as a coadjuvant drug in the integral management of abdominal sepsis acknowledged by surgery.
Read the detailed description
The sepsis is often lethal, the mortality's ranks are identified among 25 to 70%, this depends on definition, severity and co-morbidities. The number of deaths by sepsis could be similar to myocardial infarct. Patients who get shock have 26-fold risk of death.
In preliminary studies have been observed, that patients with treatment with statin have minor incidence of severe sepsis. A retrospective study suggests the association between using statins and reduction of bacteriemia by Gram negatives and S. aureus.
There are many experimental studies which demonstrate the possible profit in sepsis. However there are no clinical prospective studies for determinate if statins are effective in management of sepsis. The investigators designed this study to demonstrate the utility of rosuvastatin in one kind of sepsis, abdominal sepsis.
- Conditions
- Sepsis
- Being tested
- Rosuvastatin
- Keywords
- abdominal sepsis, sepsis, rosuvastatin
- Medical subject headings
- Sepsis, Intraabdominal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosuvastatinDrug
Also called Crestor
20 mg 10 days daily since abdominal sepsis diagnosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasmatic levels of Interleukine 6 and 1B, and Tumor Necrosis Factor alpha (pg/dL)
Measured: day 3
Secondary outcomes (4)
Number of survivors
in-patient follow-up will be considered as well
Measured: 1 week after randomization
Plasmatic levels of Reactive C Protein (mg/dL)
Measured: day 3
Classification of severity by APACHE II scale
Measured: day 3
Incidence of complications or secondary effects
Measured: day 1, 3, 7, 14 after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2006 (estimated)
- Study startAug 2006
- Primary completionJul 2011 (estimated)
- Study completionSep 2011 (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
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de San Luis Potosí
- Sponsor type
- University, hospital or other
- Investigators
- Martin Sanchez-Aguilar, MSc, Principal investigator, Experimental Surgery , Universidad Autonoma de San Luis Potosi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00357123
- Sponsor's protocol ID
- 28-08 ROAS
- Status last verified
- Sep 2010
- First submitted
- 26 Jul 2006
- Last updated
- 21 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Rosuvastatin in Integral Management of Abdominal Sepsis
- ClinicalTrials.gov ID
- NCT00357123
- Acronym / sponsor ID
- 28-08 ROAS
- Conditions
- Sepsis
- Keywords
- abdominal sepsis, sepsis, rosuvastatin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universidad Autonoma de San Luis PotosíUniversity, hospital or other
- Study start
- Aug 2006
- Primary completion
- Jul 2011 (estimated)
- Study completion
- Sep 2011 (estimated)
- First posted
- 27 Jul 2006 (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 rosuvastatin is effective as a coadjuvant drug in the integral management of abdominal sepsis acknowledged by surgery.
Detailed description
The sepsis is often lethal, the mortality's ranks are identified among 25 to 70%, this depends on definition, severity and co-morbidities. The number of deaths by sepsis could be similar to myocardial infarct. Patients who get shock have 26-fold risk of death.
In preliminary studies have been observed, that patients with treatment with statin have minor incidence of severe sepsis. A retrospective study suggests the association between using statins and reduction of bacteriemia by Gram negatives and S. aureus.
There are many experimental studies which demonstrate the possible profit in sepsis. However there are no clinical prospective studies for determinate if statins are effective in management of sepsis. The investigators designed this study to demonstrate the utility of rosuvastatin in one kind of sepsis, abdominal sepsis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Man or women > 18 and < 80 years old with abdominal sepsis, confirmed diagnosis by surgery of broad peritonitis before 48 hours in progression
- Injury by steel or firearm with contaminated abdominal cavity
- APACHE II major or equal than 8
- Acceptance to be included
Key exclusion criteria (9 listed)
- Ingestion of: fibrates, niacin, cyclosporin, azoles, macrolides, inhibitors of protease, nefazodone, verapamil, diltiazem, amiodarone
- Hypovolemic shock III and IV after get surgery
- Cardio-respiratory failure pre or trans surgery
- Allergy to used drug
- Use previous of statin
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 |
|---|---|---|
| RosuvastatinAlso: Crestor20 mg 10 days daily since abdominal sepsis diagnosis | Drug | – |
Primary outcome
Plasmatic levels of Interleukine 6 and 1B, and Tumor Necrosis Factor alpha (pg/dL)
Time frame: day 3
4 secondary outcomes
Number of survivors
Time frame: 1 week after randomization
Plasmatic levels of Reactive C Protein (mg/dL)
Time frame: day 3
Classification of severity by APACHE II scale
Time frame: day 3
Incidence of complications or secondary effects
Time frame: day 1, 3, 7, 14 after randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2011.
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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.
Martin Sanchez-Aguilar, MSc principal investigator
Experimental Surgery , Universidad Autonoma de San Luis Potosi
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 Rosuvastatin in people with Sepsis, run by Universidad Autonoma de San Luis Potosí at 1 site in Mexico.
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 4 inclusion and 9 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 21 Feb 2011. 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 Mexico. 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. 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 Martin Sanchez-Aguilar, MSc (524448262345, jemarsan7@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasmatic levels of Interleukine 6 and 1B, and Tumor Necrosis Factor alpha (pg/dL) (time frame: day 3). 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 21 Feb 2011.