Randomised double-blind placebo-controlled trial of 40 mg/day of Atorvastatin on reduction in severity of SEPSIS in ward patients

Completed

Conditions: Sepsis
Injury, Occupational Diseases, Poisoning

Registration Number: ISRCTN64637517

Lead Sponsor: Heart of England Foundation Trust (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 414

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sepsis converting to severe sepsis.

Secondary Outcome Measures

Name	Time	Method
1. Secondary outcomes are measured as admission to critical care.<br>2. Length of hospital stay.<br>3. 28 day mortality.<br>4. Euroqol questionnaire score