Additional identifiers
EudraCT number
2005-004636-52
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
ASEPSIS
Study hypothesis
Acute use of atorvastatin 40 mg/day in Accident and Emergency (A&E) and ward patients with sepsis will significantly reduce rates of sepsis converting to severe sepsis compared with placebo in previously non-statin treated patients.
Ethics approval
Approved by South Birmingham Research Committee (CTA NUMBER 24698/0003/001-0001; MREC approval number 05/Q2707/369; EudraCT number 2005-004636-52).
Study design
Double-blind randomised placebo-controlled trial interventional study using 40 mg oral atorvastatin once daily or 40 mg oral placebo once daily.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Sepsis
Intervention
Patients will receive a single tablet of either atorvastatin 40 mg or identical placebo daily for the duration of their hospital stay or 28 days if earlier.
Intervention type
Drug
Phase
Not Specified
Drug names
Atorvastatin
Primary outcome measures
Sepsis converting to severe sepsis.
Secondary outcome measures
1. Secondary outcomes are measured as admission to critical care.
2. Length of hospital stay.
3. 28 day mortality.
4. Euroqol questionnaire score
Overall trial start date
07/07/2006
Overall trial end date
01/01/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. Aged more than 18 years
2. Patients history suggestive of a new infection such as pneumonia, empyema, Urinary Tract Infection (UTI), meningitis, skin/soft tissue inflammation, acute abdominal infection, bone/joint infection, wound infection, catheter or device infection or endocarditis
3. More than or equal to two of the following signs and symptoms of infection both present and new to the patient including:
a. temperature more than 38°C or 36°C
b. chills with rigors
c. heart rate more than 90 beats per minute
d. respiratory rate more than 20 bpm, or
e. headache with stiff neck
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
414 participants, 207 in each study group across one site
Participant exclusion criteria
1. Signs of severe sepsis
2. Known active liver disease, alcohol abuse or persistantly abnormal liver function tests
3. Alanine aminotransferase more than two times the upper limit of normal laboratory ranges
4. Creatine kinase more than three times the upper limit of laboratory normal ranges
5. Pregnancy, breast feeding or women of child bearing potential not using adequate contraception
6. Previous adverse reaction to statins
7. Concomitant use of fibrates or other lipid lowering therapy
8. Administration of Atorvastatin was ceased less than or equal to two weeks prior to the trial
9. Concomitant use of erythromycin, telithromycin, clarithromycin, itraconazole, imidazoles, triazoles, cyclosporin or grapefruit juice
10. Patients in another clinical trial
11. Patients with terminal cancer
12. Known ileus
13. Failure to obtain written consent
14. Inability to swallow tablets safely
Recruitment start date
07/07/2006
Recruitment end date
01/01/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Anaesthesia
Birmingham
B9 5SS
United Kingdom
Sponsor information
Organisation
Heart of England Foundation Trust (UK)
Sponsor details
Birmingham Heartlands Hospital
Bordesley Green East
Birmingham
B9 5SS
United Kingdom
Sponsor type
Charity
Website
Funders
Funder type
Industry
Funder name
Pfizer Global Pharmaceuticals (International)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The Moulton Charitable Fund (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/23232151
Publication citations
-
Results
Patel JM, Snaith C, Thickett DR, Linhartova L, Melody T, Hawkey P, Barnett AH, Jones A, Hong T, Cooke MW, Perkins GD, Gao F, Randomized double-blind placebo-controlled trial of 40 mg/day of atorvastatin in reducing the severity of sepsis in ward patients (ASEPSIS Trial)., Crit Care, 2012, 16, 6, R231, doi: 10.1186/cc11895.