|
Welcome
|
|
09 February 2010
|
|
|
| home | my details | ISRCTN Register | mRCT | UKCTG | links | information | press |
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
| [ Print-friendly version ] |
| Randomised double-blind placebo-controlled trial of 40 mg/day of Atorvastatin on reduction in severity of SEPSIS in ward patients |
| ISRCTN | ISRCTN64637517 |
| ClinicalTrials.gov identifier | |
| Public title | Randomised double-blind placebo-controlled trial of 40 mg/day of Atorvastatin on reduction in severity of SEPSIS in ward patients |
| Scientific title | |
| Acronym | ASEPSIS |
| Serial number at source | N/A |
| 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. |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Sepsis |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 07/07/2006 |
| Anticipated end date | 01/01/2008 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 414 participants, 207 in each study group across one site |
| Interventions | 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. |
| Primary outcome measure(s) | Sepsis converting to severe sepsis. |
| Secondary outcome measure(s) |
1. Secondary outcomes are measured as admission to critical care.
2. Length of hospital stay. 3. 28 day mortality. 4. Euroqol questionnaire score |
| Sources of funding |
1. Pfizer Global Pharmaceuticals (International)
2. The Moulton Charitable Fund (UK) |
| Trial website | |
| Publications | |
| Contact name | Prof Fang Gao |
| Address |
Department of Anaesthesia
Critical Care and Pain 2nd Floor Lincoln House Birmingham Heartlands Hospital Bordesley Green East |
| City/town | Birmingham |
| Zip/Postcode | B9 5SS |
| Country | United Kingdom |
| Sponsor | Heart of England Foundation Trust (UK) |
| Address |
Birmingham Heartlands Hospital
Bordesley Green East |
| City/town | Birmingham |
| Zip/Postcode | B9 5SS |
| Country | United Kingdom |
| Sponsor website: | http://www.heartofengland.nhs.uk/ |
| Date applied | 06/07/2006 |
| Last edited | 04/01/2007 |
| Date ISRCTN assigned | 04/01/2007 |
|
|
|
|
|
| © ISRCTN | |
|
|
|
|