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

Withdrawn before enrolling · Not applicable · Has a placebo group

Conditions studied: Adult Respiratory Distress Syndrome, Acute Lung Injury

In brief

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.

Key facts

Study ID

NCT01195428

Run by

University of Oklahoma

People needed

0

Starts

2010-10-01

Expected to finish

2011-10-01

Last updated by the study team

2014-01-07

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• OU Medical Center — Oklahoma City, Oklahoma, United States
• Veterans Affairs Medical Center — Oklahoma City, Oklahoma, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.