Simvastatin Effect on the Incidence of Acute Lung Injury/Adult Respiratory Distress Syndrome (ALI/ARDS)

• Status: Withdrawn
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Oklahoma
• Collaborators: US Department of Veterans Affairs; VA Office of Research and Development
• Treatments: Simvastatin

Criteria

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)