Randomised double-blind placebo-controlled trial of 40 mg/day of Atorvastatin on reduction in severity of SEPSIS in ward patients
| ISRCTN | ISRCTN64637517 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN64637517 |
| EudraCT/CTIS number | 2005-004636-52 |
| Secondary identifying numbers | N/A |
- Submission date
- 06/07/2006
- Registration date
- 04/01/2007
- Last edited
- 07/02/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Fang Gao
Scientific
Scientific
Department of Anaesthesia
Critical Care and Pain
2nd Floor Lincoln House
Birmingham Heartlands Hospital
Bordesley Green East
Birmingham
B9 5SS
United Kingdom
Study information
| 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 |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study acronym | ASEPSIS |
| Study objectives | 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(s) | Approved by South Birmingham Research Committee (CTA NUMBER 24698/0003/001-0001; MREC approval number 05/Q2707/369; EudraCT number 2005-004636-52). |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Atorvastatin |
| Primary outcome measure | 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 study start date | 07/07/2006 |
| Completion date | 01/01/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 414 participants, 207 in each study group across one site |
| Key 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 |
| Key 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 |
| Date of first enrolment | 07/07/2006 |
| Date of final enrolment | 01/01/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Anaesthesia
Birmingham
B9 5SS
United Kingdom
B9 5SS
United Kingdom
Sponsor information
Heart of England Foundation Trust (UK)
Charity
Charity
Birmingham Heartlands Hospital
Bordesley Green East
Birmingham
B9 5SS
United Kingdom
| Website | http://www.heartofengland.nhs.uk/ |
|---|
Funders
Funder type
Industry
Pfizer Global Pharmaceuticals (International)
No information available
The Moulton Charitable Fund (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 11/12/2012 | Yes | No |
