EUCTR2010-020763-20-IE进行中（未招募）1 期
Hydroxymethylglutaryl-CoA reductase inhibition with simvastatin in Acute lung injury to Reduce Pulmonary dysfunction(HARP 2) - Simvastatin in ALI (HARP 2)
ational University of Ireland, Galway0 个研究点目标入组 540 人开始时间: 2010年8月4日最近更新:
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相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 540
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Patient must be receiving invasive mechanical ventilation
- •2. Patient must have ALI as defined by acute onset of:
- •a) hypoxic respiratory failure (PaO2/FiO2 = 40 kPa from 2 arterial blood gases >1 hour apart).
- •b) bilateral infiltrates on chest X-ray consistent with pulmonary oedema.
- •c) No clinical evidence of left atrial hypertension or if measured, a pulmonary arterial occlusion pressure (PAOP) less than or equal to 18 mmHg. If a patient has a PAOP > 18 mmHg, then the other criteria must persist for more than 12 hours after the PAOP has declined to < 18 mmHg, and still be within the 48-hour enrolment window
- •Acute onset is defined as follows: the duration of the hypoxia criterion (a) and the chest X-ray criterion (b) must be <28 days at the time of randomisation.
- •Infiltrates considered consistent with pulmonary oedema” include any patchy or diffuse infiltrates not fully explained by mass, atelectasis, or effusion or opacities known to be chronic (>28 days). The findings of vascular redistribution, indistinct vessels, and indistinct cardiac borders are not considered consistent with pulmonary oedema”.
- •All ALI criteria (a-c above) must occur within the same 24 hour period. The time of onset of ALI is when the last ALI criterion is met. Patients must be enrolled within 48 hours of ALI onset
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 25
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 130
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 115
排除标准
- •1. Age < 16 years
- •2. More than 48 hours from the onset of ALI
- •3. Patient is 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, erythromycin, clarithromycin, HIV protease inhibitors, nefazodone, cyclosporine, amiodarone, verapamil or diltiazem. Patients receiving low dose erythromycin as a prokinetic will not be excluded
- •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, AST values may be obtained up to 72 hours prior to randomisation.
研究者
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