Simvastatin and severe sepsis

Not Applicable

Completed

Conditions: Severe sepsis
Infections and Infestations
Septicaemia

Registration Number: ISRCTN92093279

Lead Sponsor: Oxford Radcliffe Hospitals NHS Trust (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 104

Inclusion Criteria

Patients eligible for inclusion:
1. Those admitted to the Adult Intensive Care Unit at John Radcliffe Hospital, Royal Sussex County Hospital and the Royal Berkshire Hospital (last two centres added 10/10/2007)
2. Severe sepsis or develop severe sepsis whilst in intensive care

Patients must be randomised and receive the first dose of simvastatin within 24 hours of first organ dysfunction to be included in the study.

Exclusion Criteria

Patients will be excluded from the trial if they:
1. Are receiving simvastatin or another statin prior to admission
2. Refuse consent or their relatives refuse assent
3. Are less than 16 years of age
4. Are included in another interventional study
5. Have a known adverse reaction to statins
6. Have an indication or contraindication to treatment with a statin, according to the treating physician
7. Are unable to receive enteral medications
8. Are receiving drugs known to interact with simvastatin
9. Have active liver disease
10. Have severe renal impairment (anuria) (removed from protocol as of 10/10/2007: creatinine >400 µmol.l^-1 or requirement for renal replacement therapy despite adequate haemodynamic resuscitation)
11. Are at high risk of rhabdomyolysis [multiple trauma, crush injuries, extensive burns, baseline creatinine kinase (CK) =five-times upper limit of normal (ULN)]
12. Have a history of known or suspected porphyria
13. Are unlikely to survive more than 24 hours
14. Are unable to speak English (or whose relatives are unable to speak English) and a suitable interpreter cannot be found

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The difference in plasma IL-6 concentration between simvastatin and placebo treated groups, on day 3 of treatment. Plasma IL-6 will be measured using a commercially available enzyme linked immunosorbent assay (ELISA) kit. This technique has been used in other recent studies and is familiar to research staff in the department.

Secondary Outcome Measures