Grant: Therapeutic approaches for H1N1 complications in the intensive care unit

Study Design: A multinational, double blind, placebo-controlled pilot RCT involving 80 patients in the general ICUs of 30 centres. Primary Objective: The primary objective of the CHAT Pilot Trial is to assess our ability to recruit the desired patient population (i.e., the proportion of eligible patients enrolled in the trial). Secondary Objectives: To evaluate (i) adherence to the medication administration regimen as outlined in the study protocol, (ii) the ability for research staff to collect the required primary and secondary endpoints for the planned full CHAT trial, (iii) the number of study withdrawals due to administration of open-label statins and consent withdrawals and (iv) the impact of the approved consent model on recruitment rates. Population: We will include critically ill adults admitted for any reason with suspected (at least moderate suspicion), probable or confirmed H1N1 infection requiring mechanical ventilation and receiving antiviral therapy for less than or equal to 72 hours. Intervention: Rosuvastatin or an identical appearing placebo will be administered once daily through an enteral feeding tube or orally, when feasible, (40 mg loading dose on day 1 followed by a 20 mg maintenance dose days 2-14). Dose adjustments will be made according to a dose adjustment algorithm. Statistical Analysis: We will consider the study to be feasible, if we (i) recruit at least 30% (commonly used threshold in ICU studies) of all eligible patients in participating ICUs either in comparison to the Swine Flu ICU Study Registry or by careful review of site screening logs. We expect that: (i) less than 10% of medication doses will fail to be administered, (ii) less than 5% of data forms will be missing important primary and secondary outcomes data and (iii) no more than 10% of enrolled patients will be withdrawn prematurely. We will describe recruitment rates based on approved consent models.