ISRCTN64637517
Completed
Not Applicable
Randomised double-blind placebo-controlled trial of 40 mg/day of Atorvastatin on reduction in severity of SEPSIS in ward patients
Heart of England Foundation Trust (UK)0 sites414 target enrollmentJanuary 4, 2007
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Sepsis
- Sponsor
- Heart of England Foundation Trust (UK)
- Enrollment
- 414
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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