Statins for Acutely Injured Lungs From Sepsis

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Sepsis, Acute Lung Injury

In brief

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.

Key facts

Study ID

NCT00979121

Run by

National Heart, Lung, and Blood Institute (NHLBI)

People needed

745

Starts

2010-01-01

Expected to finish

2013-11-01

Last updated by the study team

2016-05-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 1. 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
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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