The effect of hydroxyl-methyl coenzyme A reductase inhibition (statins) in patients with acute lung injury(ALI) and the acute respiratory distress syndrome(ARDS) - Statins in acute lung injury

• Conditions: Acute Lung Injury (ALI) and the Acute Respiratory Distress Syndrome (ARDS)

• Registration Number: EUCTR2006-001414-33-GB
• Lead Sponsor: The Royal Group Hospitals Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07-31
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Mechanically ventilated adult patients admitted to the intensive care unit at the Royal Victoria Hospital, within 48 hours of the onset ALI or ARDS, will be eligible for inclusion in the study. ALI and ARDS will be defined according to the American European Consensus Conference definition . Severe sepsis will be defined as in prior studies . Patients will be prospectively screened daily to see if they fulfil the inclusion criteria for recruitment to the study.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Age < 18 years; pregnancy; creatinine kinase (CK) > 10 times upper limit normal range, transaminases > 3 times upper limit normal range; participation in other intervention trials within previous 30 days; current treatment with statins; contraindication to enteral nutrition; unlikely to survive beyond 48 hours; patients with significant end stage disease as previously defined and assent declined from the next of kin.
These criteria are designed to include those critically patients who are likely to benefit from the therapeutic intervention and exclude patients unlikely to benefit from the intervention (not likely to survive beyond 48 hours, patients with significant end stage disease). Patients with ALI/ARDS for more than 48 hours are excluded to evaluate more clearly the effects of simvastatin early in the course of lung injury.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified