Hydroxymethylglutaryl-CoA reductase inhibition with simvastatin in mechanically ventilated patients at high risk of delirium: a randomised double-blind placebo controlled trial

West Hertfordshire Hospitals NHS Trust (UK)0 个研究点目标入组 142 人开始时间: 2013年3月26日最近更新: 2018年6月11日

适应症

试验速览

•1. Patients requiring mechanical ventilation within 72 hours of admission to intensive care.
•2. Male & Female ; Lower Age Limit 18 years

•1. Age less than 18 years
•2. Patient known to be pregnant
•3. Known allergy to statin drugs
•4. CK > 10 times upper limit of normal range
•5. Alanine aminotransferase (ALT) >8 times the upper limit of 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. Uncomplicated elective surgery
•8. Patient expected to be discharged within 48 hours of admission
•9. Patients with severe renal impairment (estimated creatinine clearance less than 30ml/minute) not receiving renal replacement therapy
•10. Severe liver disease
•11. Current or recent treatment (within 2 weeks) with statins
•12. Physician decision that a statin is required for proven indication
•13. Contraindication to enteral drug administration, e.g. patients with mechanical bowel obstruction. Patients with high gastric aspirates due to an ileus are not excluded.
•14. Known participation in investigational medicinal product (IMP) trials within 30 days
•15. Consent declined
•16. Treatment withdrawal likely within 48 hours
•17. Non-English speaking patients or those who do not adequately understand verbal or written information

发起方

West Hertfordshire Hospitals NHS Trust (UK)