Abstract | BACKGROUND: METHODS/DESIGN: Patients fulfilling the American-European Consensus Conference Definition of ALI will be randomized in a 1:1 ratio to receive enteral simvastatin 80 mg or placebo once daily for a maximum of 28 days. Allocation to randomized groups will be stratified with respect to hospital of recruitment and vasopressor requirement. Data will be recorded by participating ICUs until hospital discharge, and surviving patients will be followed up by post at 3, 6 and 12 months post randomization. The primary outcome is number of ventilator-free days to day 28. Secondary outcomes are: change in oxygenation index and sequential organ failure assessment score up to day 28, number of non pulmonary organ failure free days to day 28, critical care unit mortality; hospital mortality; 28 day post randomization mortality and 12 month post randomization mortality; health related quality of life at discharge, 3, 6 and 12 months post randomization; length of critical care unit and hospital stay; health service use up to 12 months post-randomization; and safety. A total of 540 patients will be recruited from approximately 35 ICUs in the UK and Ireland. An economic evaluation will be conducted alongside the trial. Plasma and urine samples will be taken up to day 28 to investigate potential mechanisms by which simvastatin might act to improve clinical outcomes. TRIAL REGISTRATION: Current Controlled Trials ISRCTN88244364.
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Authors | Daniel F McAuley, John G Laffey, Cecilia M O'Kane, Mark Cross, Gavin D Perkins, Lynn Murphy, Christine McNally, Grainne Crealey, Michael Stevenson, HARP-2 investigators, Irish Critical Care Trials Group |
Journal | Trials
(Trials)
Vol. 13
Pg. 170
(Sep 17 2012)
ISSN: 1745-6215 [Electronic] England |
PMID | 22985805
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Simvastatin
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Topics |
- Acute Lung Injury
(diagnosis, drug therapy, economics, mortality, physiopathology)
- Clinical Protocols
- Cost-Benefit Analysis
- Double-Blind Method
- Drug Costs
- Hospital Costs
- Hospital Mortality
- Humans
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
(adverse effects, economics, therapeutic use)
- Ireland
- Length of Stay
- Lung
(drug effects, physiopathology)
- Prospective Studies
- Quality of Life
- Recovery of Function
- Research Design
- Respiration, Artificial
- Simvastatin
(adverse effects, economics, therapeutic use)
- Time Factors
- Treatment Outcome
- United Kingdom
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