ISRCTN88244364已完成2 期
Hydroxymethylglutaryl-CoA reductase inhibition with simvastatin in Acute lung injury to Reduce Pulmonary dysfunction (HARP 2)
Belfast Health and Social Care Trust (UK)0 个研究点目标入组 540 人开始时间: 2010年11月26日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 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
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 14/09/2011:
- •1. Patient must be receiving invasive mechanical ventilation
- •2. Patient must have ALI [34] as defined by acute onset of:
- •2.1 Hypoxic respiratory failure (PaO2/FiO2 = 40 kPa from 2 blood gases >1 hour apart).
- •2.2 Bilateral infiltrates on chest X-ray consistent with pulmonary oedema.
- •2.3 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
- •Previous inclusion crieteria:
- •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 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.
- •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.
排除标准
- •Current exclusion criteria as of 07/09/2012:
- •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 until 07/09/2012:
- •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.
- •12. Domiciliary mechanical ventilation
- •Added 08/03/2011:
- •16. Non-english speaking patients or those who do not adequately understand verbal or written information unless an interpreter is available
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