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

The Royal Group Hospitals Trust0 个研究点目标入组 60 人开始时间: 2007年7月31日最近更新: 2012年3月19日

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•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

•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.

发起方

The Royal Group Hospitals Trust