Study Stopped
stopped for futility
Statins for Acutely Injured Lungs From Sepsis
SAILS
Randomized Trial of Rosuvastatin for Acutely Injured Lungs From Sepsis
2 other identifiers
interventional
745
1 country
40
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 sepsis
Started Jan 2010
Longer than P75 for phase_3 sepsis
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 16, 2009
CompletedFirst Posted
Study publicly available on registry
September 17, 2009
CompletedStudy Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedResults Posted
Study results publicly available
October 3, 2014
CompletedMay 16, 2016
August 1, 2014
3.8 years
September 16, 2009
August 22, 2014
April 12, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hospital Mortality to Day 60.
The percentage of subjects alive at study day 60. Those subjects discharged home prior to day 60 were counted as alive at day 60.
60 days after randomization
Secondary Outcomes (1)
Ventilator Free Days at Study Day 28
time of initiating unassisted breathing to day 28 after study randomization
Other Outcomes (4)
Organ Failure Free Days at Day 14
14 days after randomization
ICU Free Days to Day 28
28 days after randomization
Other Secondary Out-comes
28 days after randomization
- +1 more other outcomes
Study Arms (2)
Rosuvastatin
ACTIVE COMPARATORHalf 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: 1. 28 days after randomization or 3 days after ICU discharge (whichever comes first), 2. Discharge from study hospital, 3. Death
Placebo
PLACEBO COMPARATORHalf 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.
Interventions
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.
Subjects received placebo by mouth or feeding tube daily for 28 days or until discharged from study hospital.
Eligibility Criteria
You may qualify if:
- \. Systemic inflammatory response syndrome (SIRS) defined as meeting at least criteria (a) or (b)for a systemic inflammatory response:
- White blood cell count \>12,000 or \<4,000 or \>10% band forms
- Body temperature \>38 degrees Celsius (C) (any route) or \<36 degrees C (accepting core temperatures only; indwelling catheter, esophageal, rectal)
- Heart rate (\> 90 beats/min) or receiving medications that slow heart rate or paced rhythm 2. Suspected or proven infection: Sites of infection include thorax, urinary tract, abdomen, skin, sinuses, central venous catheters, and bacterial meningitis (Appendix A).
- \. ALI as defined by acute onset of:
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- PaO2 / FiO2 ≤ 300 (intubated). If altitude \> 1000m, then PaO2 / FiO2 ≤ 300 x (PB/760), and
- Bilateral infiltrates consistent with pulmonary edema on frontal chest radiograph, and
- Requirement for positive pressure ventilation via an endotracheal tube, and
- No clinical evidence of left atrial hypertension, or if measured, a Pulmonary Arterial Wedge Pressure (PAOP) less than or equal to 18 mm Hg. 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 enrollment window.
- "Acute onset" is defined as follows: the duration of the hypoxemia criterion (#1) and the chest radiograph criterion (#2) must be ≤ 28 days at the time of randomization. Opacities considered "consistent with pulmonary edema" include any patchy or diffuse opacities 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 edema".
- All ALI criteria (3a-d above) must occur within the same 24 hour period. The onset of ALI is when the last ALI criterion is met. Patients must be enrolled within 48 hours of ALI onset and no more than 7 days from the initiation of mechanical ventilation. SIRS criteria must occur within the 72 hours before or the 24 hours after ALI onset. Information for determining when these time window criteria were met may come from either the Network hospital or a referring hospital reports.
You may not qualify if:
- No consent/inability to obtain consent
- Age less than 18 years
- More than 7 days since initiation of mechanical ventilation
- Patient, surrogate, or physician not committed to full support ).
- Unable to receive or unlikely to absorb enteral study drug
- Receiving a statin medication within 48 hours of randomization
- Allergy or intolerance to statins
- Physician insistence for the use or avoidance of statins during the current hospitalization
- Creatine Kinase (CK) , alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 5 times the upper limit of normal
- Diagnosis of hypothyroidism and not on thyroid replacement therapy
- Pregnancy or breast feeding
- Receiving niacin, fenofibrate or cyclosporine, gemfibrozil, atazanavir, lopinavir, ritonavir, daptomycin
- Severe chronic liver disease
- Moribund patient not expected to survive 24 hours
- Chronic respiratory failure defined as PaCO2 \> 60 mm Hg in the outpatient setting
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (40)
University of San Francisco-Fresno Medical Center
Fresno, California, United States
University of California, Davis Medical Center
Sacramento, California, United States
UCSF-Moffitt Hospital
San Francisco, California, United States
University of California, San Francisco (UCSF)-Moffitt Hospital
San Francisco, California, United States
Centura St. Anthony Central Hospital
Denver, Colorado, United States
Denver Health Medical Center
Denver, Colorado, United States
Rose Medical Center
Denver, Colorado, United States
University of Colorado Health Sciences Center
Denver, Colorado, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
Baton Rouge General Hospital-Blue Bonnet
Baton Rouge, Louisiana, United States
Baton Rouge General Hospital-Midcity
Baton Rouge, Louisiana, United States
Earl K. Long Medical Center
Baton Rouge, Louisiana, United States
Our Lady of the Lake Regional Medical Center
Baton Rouge, Louisiana, United States
Medical Center of Louisiana
New Orleans, Louisiana, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Tulane University Health Sciences Center
New Orleans, Louisiana, United States
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
University of Maryland Shock Trauma Center
Baltimore, Maryland, United States
Baystate Medical Center
Springfield, Massachusetts, United States
Rochester Methodist Hospital
Rochester, Minnesota, United States
St. Mary's Hospital, Mayo Clinic
Rochester, Minnesota, United States
Duke University Medical Center
Durham, North Carolina, United States
Durham Regional Medical Center
Durham, North Carolina, United States
Moses Cone Health System
Greensboro, North Carolina, United States
Wesley Long Community Hospital
Greensboro, North Carolina, United States
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
MetroHealth Medical Center
Cleveland, Ohio, United States
University Hospitals of Cleveland
Cleveland, Ohio, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Baylor College of Medicine
Houston, Texas, United States
Intermountain Medical Center
Murray, Utah, United States
McKay-Dee Hospital
Ogden, Utah, United States
Utah Valley Regional Medical Center
Provo, Utah, United States
LDS Hospital
Salt Lake City, Utah, United States
University of Virginia Medical Center
Charlottesville, Virginia, United States
Providence Hospital
Everett, Washington, 98201, United States
Harborview Medical Center
Seattle, Washington, United States
University of Washington
Seattle, Washington, United States
Related Publications (4)
Yu SY, Ge ZZ, Xiang J, Gao YX, Lu X, Walline JH, Qin MB, Zhu HD, Li Y. Is rosuvastatin protective against sepsis-associated encephalopathy? A secondary analysis of the SAILS trial. World J Emerg Med. 2022;13(5):367-372. doi: 10.5847/wjem.j.1920-8642.2022.072.
PMID: 36119770DERIVEDDinglas VD, Hopkins RO, Wozniak AW, Hough CL, Morris PE, Jackson JC, Mendez-Tellez PA, Bienvenu OJ, Ely EW, Colantuoni E, Needham DM. One-year outcomes of rosuvastatin versus placebo in sepsis-associated acute respiratory distress syndrome: prospective follow-up of SAILS randomised trial. Thorax. 2016 May;71(5):401-10. doi: 10.1136/thoraxjnl-2015-208017. Epub 2016 Mar 2.
PMID: 26936876DERIVEDNeedham DM, Colantuoni E, Dinglas VD, Hough CL, Wozniak AW, Jackson JC, Morris PE, Mendez-Tellez PA, Ely EW, Hopkins RO. Rosuvastatin versus placebo for delirium in intensive care and subsequent cognitive impairment in patients with sepsis-associated acute respiratory distress syndrome: an ancillary study to a randomised controlled trial. Lancet Respir Med. 2016 Mar;4(3):203-12. doi: 10.1016/S2213-2600(16)00005-9. Epub 2016 Jan 29.
PMID: 26832963DERIVEDNational Heart, Lung, and Blood Institute ARDS Clinical Trials Network; Truwit JD, Bernard GR, Steingrub J, Matthay MA, Liu KD, Albertson TE, Brower RG, Shanholtz C, Rock P, Douglas IS, deBoisblanc BP, Hough CL, Hite RD, Thompson BT. Rosuvastatin for sepsis-associated acute respiratory distress syndrome. N Engl J Med. 2014 Jun 5;370(23):2191-200. doi: 10.1056/NEJMoa1401520. Epub 2014 May 18.
PMID: 24835849DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- David A. Schoenfeld, PhD ARDSNet CCC PI
- Organization
- ARDS Network
Study Officials
- STUDY CHAIR
Jonathon Truwit, MD
University of Virginia, Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 16, 2009
First Posted
September 17, 2009
Study Start
January 1, 2010
Primary Completion
November 1, 2013
Study Completion
November 1, 2013
Last Updated
May 16, 2016
Results First Posted
October 3, 2014
Record last verified: 2014-08