ISRCTN70127774已完成不适用
Hydroxymethylglutaryl-CoA reductase inhibition in Acute lung injury to Reduce Pulmonary oedema and inflammation: a phase II, single centre, prospective, double-blind, randomised, placebo-controlled trial
The Royal Group Hospitals Trust (UK)0 个研究点目标入组 60 人开始时间: 2006年4月24日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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.
排除标准
- •Current exclusion criteria as of 17/04/2012
- •1.Age < 16 years
- •2.More than 48 hours from the onset of ALI
- •3.Patient is known to be pregnant
- •4.CK >10 times the upper limit of the normal range*
- •5.Transaminases >8 times the upper limit of the normal range*
- •6.Patients currently receiving ongoing and sustained treatment with any of the following; itraconazole, ketoconazole, HIV protease inhibitors, nefazodone, cyclosporine, amiodarone, verapamil or diltiazem.
- •7.Patients with severe renal impairment (estimated creatinine clearance less than 30ml/minute) not receiving renal replacement therapy
- •8.Severe liver disease (Child's Pugh score >12; Appendix 1)
- •9.Current or recent treatment (within 2 weeks) with statins
- •10.Physician decision that a statin is required for proven indication
- •11.Contraindication to enteral drug administration, e.g. patients with mechanical bowel obstruction. Patients with high gastric aspirates due to an ileus are not excluded.
- •12.Domiciliary mechanical ventilation except for CPAP/BIPAP used for sleep-disordered breathing.
- •13.Known participation in other investigational medicinal product (IMP) trials within 30 days
- •14.Consent declined
- •15.Treatment withdrawal imminent within 24 hours
- •16.Non-english speaking patients or those who do not adequately understand verbal or written information unless an interpreter is available
- •* If CK, ALT and AST values are not available as part of routine care, a blood sample will be obtained after informed consent but before randomisation.
- •CK, ALT and AST values may be obtained up to 72 hours prior to randomisation.
- •Previous exclusion criteria
- •1. Aged under 18 years
- •2. Pregnancy
- •3. Creatinine kinase (CK) more than five times upper limit of normal range
- •4. Transaminases more than three times upper limit of normal range
- •5. Participation in other intervention trials within previous 30 days
- •6. Current treatment with statins
- •7. Contraindication to enteral nutrition
- •8. Unlikely to survive beyond 48 hours
- •9. Patients with significant end stage disease as previously defined and assent declined from the next of kin
研究者
相似试验
进行中（未招募）
不适用
A study to determine whether Simvastatin is of therapeutic value in patients with acute lung injury (ALI)Acute lung injuryEUCTR2010-020763-20-GBBelfast Health & Social Care Trust
已完成
2 期
Simvastatin in acute lung injuryLung injuryAcute lung injuryRespiratoryISRCTN88244364Belfast Health and Social Care Trust (UK)540
进行中（未招募）
1 期
Testing if simvastatin reduces delirium - acute confusion - in intensive care patients.DeliriumEUCTR2012-003114-13-GBWest Hertfordshire Hospitals NHS Trust142
进行中（未招募）
1 期
Many patients admitted to the Intensive Care Unit (ICU) have a breathing machine, or ventilator, to help them breathe and ensure that enough oxygen gets into their blood. For reasons that are unclear, when people are critically ill their lungs often fail, which is termed acute lung injury (ALI). This study is being conducted to find out if Simvastatin is effective in the treatment of ALI by testing it in a larger number of patients.Acute lung injuryEUCTR2010-020763-20-IEational University of Ireland, Galway540
已完成
不适用
Modifying Delirium Using SimvastatiTopic: Generic Health Relevance and Cross Cutting ThemesSubtopic: Generic Health Relevance (all Subtopics)Disease: Critical CareMental and Behavioural DisordersPostoperative deliriumISRCTN89079989West Hertfordshire Hospitals NHS Trust (UK)142