Status:
WITHDRAWN
Simvastatin Effect on the Incidence of Acute Lung Injury/Adult Respiratory Distress Syndrome (ALI/ARDS)
Lead Sponsor:
University of Oklahoma
Collaborating Sponsors:
US Department of Veterans Affairs
Conditions:
Adult Respiratory Distress Syndrome
Acute Lung Injury
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 p...
Detailed Description
Patients will be enrolled within 24 hours of ICU admission and randomized to 1 of 2 groups: Simvastatin or placebo. Patients' management will be entirely left up to the primary team, including the nee...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01195428
Start Date
October 1 2010
End Date
October 1 2011
Last Update
January 7 2014
Active Locations (2)
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1
OU Medical Center
Oklahoma City, Oklahoma, United States, 73104
2
Veterans Affairs Medical Center
Oklahoma City, Oklahoma, United States, 73104