Acute Lung Injury Clinical Trial
Official title:
Simvastatin Effect on the Incidence of Acute Lung Injury/Adult Respiratory Distress Syndrome
Verified date | January 2014 |
Source | University of Oklahoma |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
Acute Lung Injury/Acute respiratory distress syndrome (ALI/ARDS) is a serious and frequently encountered entity in modern ICUs. Sepsis remains the most common cause of ALI/ARDS and carries the worst prognosis. The disease is characterized by an intense inflammatory process. This inflammation plays a major role in the development of gas exchange abnormalities seen in the course of the disease. Statins, primarily used as lipid-lowering agents, are now known to possess anti-inflammatory, antioxidant, antithrombogenic and vascular function-restoring actions. Therefore the investigators propose to determine if Simvastatin may be useful in decreasing the incidence of this deadly syndrome in critically ill patients.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | October 2011 |
Est. primary completion date | October 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Adults older than 18 years of age, admitted to the ICU with one or more of the following risk factors for ARDS/ALI: - Sepsis, defined as the presence of infection-related systemic inflammatory response syndrome (SIRS). SIRS is defined as the presence of two or more of the following: - Temperature >38.5ºC or <35ºC - Heart rate >90 beats/min - Respiratory rate >20 breaths/min or PaCO2 <32 mmHg - WBC >12,000 cells/mm3, <4000 cells/mm3, or >10 percent immature (band) forms - Pneumonia, including community and health care associated pneumonias - Aspiration, defined as the witnessed inhalation of gastric contents - Acute pancreatitis - Bilateral lung contusion - Massive transfusion, defined as more than 15 units of red blood cells/24h - Multiple (>2) long-bone fractures Exclusion Criteria: - Patients already on a statin - Current indication for statin therapy according to the National guidelines - NPO order - Active liver disease, defined as ALT or AST > 3 times the upper limits of normal - History of myopathy - History of uncontrolled seizure disorder - Pregnancy or breastfeeding - Immunosuppressive therapy, including prednisone at dose > 10 mg/day - Preexistent lung disease indicated by history or chest film - High risk for cardiogenic pulmonary edema (defined as the presence of ventricular fibrillation, acute myocardial infarction, congestive heart failure with EF < 40%) - High risk for neurogenic pulmonary edema (active CVA, or known increased intracranial pressure) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | OU Medical Center | Oklahoma City | Oklahoma |
United States | Veterans Affairs Medical Center | Oklahoma City | Oklahoma |
Lead Sponsor | Collaborator |
---|---|
University of Oklahoma | VA Office of Research and Development |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of ARDS/ALI. | 4 weeks | No |
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