Condition category
Injury, Occupational Diseases, Poisoning
Date applied
06/07/2006
Date assigned
04/01/2007
Last edited
07/02/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Fang Gao

ORCID ID

Contact details

Department of Anaesthesia
Critical Care and Pain
2nd Floor Lincoln House
Birmingham Heartlands Hospital
Bordesley Green East
Birmingham
B9 5SS
United Kingdom

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

http://www.heartofengland.nhs.uk/

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

  1. 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.

Additional files

Editorial Notes