A Study of Statins for Acutely Injured Lungs from Sepsis


About this study

The purpose of this study is to assess the effectiveness and safety of oral rosuvastatin for the treatment of patients who have sepsis-induced acute lung injury.


Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

  • Systemic inflammatory response syndrome defined as meeting criteria 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 such as indwelling catheter, esophageal, rectal)
  • Heart rate (> 90 beats/min) or receiving medications that slow heart rate or paced rhythm
  • Suspected or proven infection of the thorax, urinary tract, abdomen, skin, sinuses, central venous catheters, or bacterial meningitis
  • ALI as defined by acute onset of
    • PaO2 / FiO2 ≤ 300 intubated
    • If altitude > 1000m, then PaO2 / FiO2 ≤ 300 x (PB/760)
    • Bilateral infiltrates consistent with pulmonary edema on frontal chest radiograph
    • Requirement for positive pressure ventilation via an endotracheal tube
    • 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 the duration of the hypoxemia and the chest radiograph criteria 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 must occur within the same 24 hour period
    • The onset of ALI is when the last ALI criterion is met
    • 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

Exclusion Criteria

  • No consent and unable to obtain consent
  • Age less than 18 years
  • More than 7 days since initiation of mechanical ventilation
  • More than 48 hours since meeting ALI inclusion criteria
  • Patient, surrogate, or physician not committed to full support
  • Unable to receive or unlikely to absorb enteral study drug
  • Rosuvastatin specific exclusions
    • 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
  • Home mechanical ventilation (noninvasive ventilation or via tracheotomy) except for CPAP/BIPAP (Continuous Positive Airway Pressure/BiLevel Positive Airway Pressure) used solely for sleep-disordered breathing
  • Diffuse alveolar hemorrhage from vasculitis
  • Burns > 40% total body surface
  • Interstitial lung disease of severity sufficient to require continuous home oxygen therapy
  • Unwillingness or inability to utilize the ARDS network 6 ml/kg Predicted Body Weight (PBW) ventilation protocol
  • Cardiac disease classified as NYHA (New York Heart Association) class IV
  • Myocardial infarction within past 6 months
  • Intraparenchymal Central Nervous System (CNS) bleed within a month of randomization
  • Temperature >40.3 C in the 6 hours before randomization

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Rolf Hubmayr, M.D.

Closed for enrollment

Jacksonville, Fla.

Mayo Clinic principal investigator

Rolf Hubmayr, M.D.

Closed for enrollment

More information


Publications are currently not available

Mayo Clinic Footer