NCT00357123

Brief 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.

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
60

participants targeted

Target at P25-P50 for phase_2 sepsis

Timeline
Completed

Started Aug 2006

Longer than P75 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

First Submitted

Initial submission to the registry

July 26, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 27, 2006

Completed
5 days until next milestone

Study Start

First participant enrolled

August 1, 2006

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

February 21, 2011

Status Verified

September 1, 2010

Enrollment Period

4.9 years

First QC Date

July 26, 2006

Last Update Submit

February 18, 2011

Conditions

Sepsis

Keywords

abdominal sepsissepsisrosuvastatin

Outcome Measures

Primary Outcomes (1)

  • Plasmatic levels of Interleukine 6 and 1B, and Tumor Necrosis Factor alpha (pg/dL)

    day 3

Secondary Outcomes (4)

  • Number of survivors

    1 week after randomization

  • Plasmatic levels of Reactive C Protein (mg/dL)

    day 3

  • Classification of severity by APACHE II scale

    day 3

  • Incidence of complications or secondary effects

    day 1, 3, 7, 14 after randomization

Interventions

RosuvastatinDRUG

20 mg 10 days daily since abdominal sepsis diagnosis

Also known as: Crestor

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • Management in other Hospital
  • Pregnancy
  • Thoracic injury, head injury (moderate and severe), multiple fractures or with bone exposition, rectal injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Central "Dr. Ignacio Morones Prieto

San Luis Potosí City, San Luis Potosí, 78240, Mexico

RECRUITING

MeSH Terms

Conditions

SepsisIntraabdominal Infections

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Martin Sanchez-Aguilar, MSc

    Experimental Surgery , Universidad Autonoma de San Luis Potosi

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin Sanchez-Aguilar, MSc

CONTACT

524448262345jemarsan7@hotmail.com

Antonio Gordillo-Moscoso, PhD

CONTACT

524448262345gordillo@uaslp.mx

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 26, 2006

First Posted

July 27, 2006

Study Start

August 1, 2006

Primary Completion

July 1, 2011

Study Completion

September 1, 2011

Last Updated

February 21, 2011

Record last verified: 2010-09

Locations

ME(1)