A double-blind placebo-controlled randomised pilot trial of the utility of statins as an adjuvant anti-inflammatory treatment in critically ill adults with suspected, probable or confirmed H1N1

St Michael's Hospital (UK)0 个研究点目标入组 80 人开始时间: 2010年3月8日最近更新: 2019年4月1日

适应症

试验速览

•1. Critically ill adult patients greater than 16 years of age (either sex) admitted to an adult intensive care unit (ICU) for any reason with suspected, probable or confirmed novel swine origin influenza A/H1N1 infection
•2. Requiring mechanical ventilation (invasive or non-invasive)
•3. Receiving antiviral therapy (any medication at any dose and for any intended duration) for less than 72 hours
•4. Attending physician or intensivist must have a 'moderate' to 'high' index of suspicion for H1N1

•1. Aged less than 16 years
•2. Do not resuscitate or re-intubate order documented on chart or anticipated withdrawal of life support
•3. Weight less than 40 kg
•4. Unable to receive or unlikely to absorb enteral study drug (e.g. incomplete or complete bowel obstruction, intestinal ischaemia, infarction, short bowel syndrome)
•5. Rosuvastatin specific exclusions:
•5.1. Already receiving a statin (atorvastatin, lovastatin, simvastatin, pravastatin, rosuvastatin)
•5.2. Allergy or intolerance to statins
•5.3. Receiving niacin, fenofibrate, cyclosporine, gemfibrozil, any protease inhibitor (including but not limited to lopinavir, ritonavir) or planned use of oral contraceptives or estrogen therapy during the Intensive Care Unit (ICU) stay
•5.4. Creatine kinase (CK) exceeds 5,000 U/L or alanine aminotransferase (ALT) exceeds 8 times the upper limit of normal (ULN)
•6. Severe chronic liver disease (Child-Pugh Score 11 - 15)
•7. Previous enrolment in this trial
•8. Pregnancy or breast feeding
•9. At the time of enrolment, receipt of greater than 72 hours of antiviral therapy
•10. Known or suspected clinically significant myositis or myopathy

发起方

St Michael's Hospital (UK)