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Original article
One-year outcomes of rosuvastatin versus placebo in sepsis-associated acute respiratory distress syndrome: prospective follow-up of SAILS randomised trial
  1. Victor D Dinglas1,2,
  2. Ramona O Hopkins3,4,5,
  3. Amy W Wozniak1,6,
  4. Catherine L Hough7,
  5. Peter E Morris8,
  6. James C Jackson9,
  7. Pedro A Mendez-Tellez1,10,
  8. O Joseph Bienvenu1,11,
  9. E Wesley Ely9,12,
  10. Elizabeth Colantuoni1,6,
  11. Dale M Needham1,2,13
  1. 1Outcomes after Critical Illness and Surgery (OACIS) Group, Johns Hopkins University, Baltimore, Maryland, USA
  2. 2Division of Pulmonary and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA
  3. 3Pulmonary and Critical Care Division, Department of Medicine, Intermountain Medical Center, Murray, Utah, USA
  4. 4Psychology Department and Neuroscience Center, Brigham Young University, Provo, Utah, USA
  5. 5Center for Humanizing Critical Care, Intermountain Health Care, Murray, Utah, USA
  6. 6Department of Biostatistics, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland, USA
  7. 7Division of Pulmonary and Critical Care Medicine, Harborview Medical Center, University of Washington, Seattle, Washington, USA
  8. 8Division of Pulmonary, Critical Care & Sleep Medicine, University of Kentucky, Lexington, Kentucky, USA
  9. 9Division of Allergy, Pulmonary, and Critical Care Medicine, Department of Medicine, Vanderbilt University School of Medicine, Nashville, Tennessee, USA
  10. 10Department of Anesthesiology and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA
  11. 11Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA
  12. 12Geriatric Research, Education and Clinical Center Service, Department of Veterans Affairs Medical Center, Tennessee Valley Healthcare System, Nashville, Tennessee, USA
  13. 13Department of Physical Medicine and Rehabilitation, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA
  1. Correspondence to Dr Dale Needham, Division of Pulmonary and Critical Care Medicine, Johns Hopkins University, 1830 E. Monument St, 5th Floor, Baltimore, MD 21205, USA; dale.needham{at}


Background Prior randomised trials have evaluated statins in patients with sepsis and acute respiratory distress syndrome (ARDS), but there has been no comprehensive evaluation of long-term effects, despite potential neuromuscular and mental health adverse effects of these drugs.

Aim To evaluate the effect of rosuvastatin versus placebo on survival, physical function and performance, and mental health outcomes in patients with sepsis-associated ARDS.

Methods Prospective follow-up evaluation of the ARDS Clinical Trials Network Statins for Acutely Injured Lungs from Sepsis trial of rosuvastatin versus placebo in 568 mechanically ventilated patients with sepsis-associated ARDS, with blinded 6-month outcome assessment performed in the 272 eligible survivors for age-adjusted and sex-adjusted 36-Item Short Form Health Survey (SF-36) physical function and mental health domains, and in 84 eligible survivors for the 6 min walk test, along with secondary outcomes evaluations of survival, and additional patient-reported and performance-based measures at 6-month and 12-month follow-up.

Results Over 1-year follow-up, there was no significant difference in cumulative survival in the rosuvastatin versus placebo groups (58% vs 61%; p=0.377), with survivors demonstrating substantial impairments in physical function and mental health. Rosuvastatin versus placebo had no effect (mean treatment effect (95% CI)) on SF-36 physical function (0 (−7 to 8), p=0.939) or mental health (−6 (−12 to 1) p=0.085) domains, 6 min walk distance (per cent predicted: 2 (−9 to 14), p=0.679) or the vast majority of secondary outcomes.

Conclusions Over 1-year follow-up, patients with sepsis-associated ARDS had high cumulative mortality, with survivors commonly experiencing impairments in physical functioning and performance, and mental health. Randomisation to rosuvastatin had no effect on these outcomes.

Trial registration number NCT00979121 and NCT00719446.

  • ARDS

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