Statins for Acutely Injured Lungs From Sepsis (SAILS)
Objective: assess the efficacy and safety of oral rosuvastatin in patients with sepsis-induced Acute Lung Injury (ALI).
Hypothesis: Rosuvastatin therapy will improve mortality in patients with sepsis-induced ALI.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
|Official Title:||Randomized Trial of Rosuvastatin for Acutely Injured Lungs From Sepsis|
- Hospital Mortality to Day 60. [ Time Frame: 60 days after randomization ]The percentage of subjects alive at study day 60. Those subjects discharged home prior to day 60 were counted as alive at day 60.
- Ventilator Free Days at Study Day 28 [ Time Frame: time of initiating unassisted breathing to day 28 after study randomization ]Ventilator Free Days (VFDs) to day 28 were defined as the number of days from the time of initiating unassisted breathing to day 28 after randomization, assuming survival for at least two consecutive calendar days after initiating unassisted breathing and continued unassisted breathing to day 28. If a subject received assisted breathing at day 27 or died prior to day 28, a value of zero VFDs was given.
- Organ Failure Free Days at Day 14 [ Time Frame: 14 days after randomization ]The number of days from randomization to day 14 without an organ failure. Four main organ systems were measured: cardiovascular, coagulation, hepatic function, and renal function.
- ICU Free Days to Day 28 [ Time Frame: 28 days after randomization ]
- Other Secondary Out-comes [ Time Frame: 28 days after randomization ]Percentage of subjects with Arrhythmia's, Bowel Ischemia, Myocardial Infarction, Ischemic Stroke, and Thromboembolism were measured.
- Changes in Plasma Concentrations of C-reactive Protein (CRP) From Baseline to Day 6 and Day 14 [ Time Frame: 6 and 14 days after randomization ]CRP levels were collected on subjects at baseline and on-study. The change in concentration from baseline levels to levels on study days 6 and 14 was analyzed. Those subjects that were still alive and on study at day 6 and 14 with a measured CRP level were included in the analysis.
|Study Start Date:||January 2010|
|Study Completion Date:||November 2013|
|Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
Active Comparator: Rosuvastatin
Half of the subjects were randomized to the active drug (Rosuvastatin).
Dosage, Form, and Frequency: drug was provided as 10mg tablets and administered through an enteral feeding tube or orally (following extubation when patients were able to safely take oral medications). An initial 40mg loading dose was administered followed by a daily 20 mg maintenance dose. Maintenance dosing was adjusted for renal failure not compensated by renal replacement therapy.
Duration: drug was administered daily until:
Subjects received an initial 40mg loading dose followed by 20 mg of study drug daily by mouth or feeding tube for 28 days or until discharged from the study hospital.
Other Name: Crestor
Placebo Comparator: Placebo
Half of the subjects were randomized to placebo.
10mg tablets identical to active drug were administered through an enteral feeding tube or orally (following extubation when patients were able to safely take oral medications). Dosage, frequency, and duration was provided in the same manner as the active drug.
Subjects received placebo by mouth or feeding tube daily for 28 days or until discharged from study hospital.
Acute Lung Injury (ALI) and Acute Respiratory Distress Syndrome (ARDS) involves extensive inflammation in the lungs that can lead to rapid respiratory failure. These conditions are most commonly caused by pneumonia, generalized infection, or severe trauma to the lungs, but can also be less commonly caused by smoke or salt water inhalation, drug overdose, or shock.
For some people, ALI/ARDS resolves without treatment, but many severe cases result in hospitalization in the intensive care unit (ICU), where 30% to 40% of cases end in mortality. Current treatments for ALI/ARDS include assisted breathing with a ventilator, supportive care, and management of the underlying causes.
Upon admission to the ICU, Rosuvastatin or placebo was administered through an enteral feeding tube or administered orally following extubation when patients were able to safely take oral medications. The type and placement of the enteral feeding tube (nasogastric, nasoenteric, PEG, orogastric, oroenteric, etc.) and the ability to safely take oral medications was determined by the patient's primary team. Study drug was blinded with an identical appearing placebo. The first study drug dose (rosuvastatin or placebo) was administered within 4 hours of randomization as a loading dose of 40 mg.
Blood pressure, heart rate, ventilation settings, and various blood factors were measured during treatment. Phone-based follow-up assessments occurred at months 6 and 12 after ICU discharge and included measurements of health-related quality of life; psychological, neurocognitive, and physical activity outcomes; healthcare utilization; and mortality.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00979121
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|Study Chair:||Jonathon Truwit, MD||University of Virginia, Medical Center|