A phase II randomised controlled trial of atorvastatin therapy in intensive care patients with severe sepsis

Funded Activity Summary

Infections are common in patients in the intensive care unit and produce inflammation that may spread throughout the body. Despite improved therapies, when infections cause failure of the body's vital organs, up to 40% of patients may die. The medication atorvastatin and other statins have been used for many years to treat and prevent conditions such as heart attack and stroke. They act primarily by reducing cholesterol production. In addition, they also modify inflammation and the immune system which may make them a useful treatment for patients with established infections. Although the statin drugs are usually safe, rare side effects may affect muscle and the liver. Because of concerns about increased risk of side effects it is currently recommended that statins should be stopped when patients become unwell. However, a number of studies have suggested that patients on statins for heart disease are less likely to develop infections and that their infections are less likely to be severe or result in death. Other studies have suggested that stopping statins in patients that present with infections (as suggested by current guidelines), may worsen infection outcomes. However, these studies have not been detailed enough to exclude all factors affecting outcome, such as patient age, severity of the infection, and the presence of other diseases. We plan to perform a study to assess the effect of atorvastatin on the outcome of infections in the intensive care unit. We will study 250 patients presenting with severe infections. We will randomly assign patients to receive either atorvastatin or placebo and monitor the effect on signs of inflammation and levels of life support. Outcomes and side effects will be carefully monitored. The study will help us decide whether to perform a larger study to determine if atorvastatin can reduce the risk of dying from serious infections.

Funded Activity Details

Start Date: 01-01-2007

End Date: 01-01-2008

Funding Scheme: NHMRC Project Grants

Funding Amount: $622,148.00

Funder: National Health and Medical Research Council

Research Topics

ANZSRC Field of Research (FoR)

Intensive Care

ANZSRC Socio-Economic Objective (SEO)

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Other Keywords

blood cholesterol levels | clinical trial | inflammatory mediators | intensive care | lipid biochemistry | pharmacokinetics | sepsis | statins

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