- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01195428
Simvastatin Effect on the Incidence of Acute Lung Injury/Adult Respiratory Distress Syndrome (ALI/ARDS)
Simvastatin Effect on the Incidence of Acute Lung Injury/Adult Respiratory Distress Syndrome
Study Overview
Status
Intervention / Treatment
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 need for daily laboratory and imaging. In addition, there will be no restriction on the use of any medications, as deemed necessary by the primary care physician. The primary endpoint will be the incidence of ALI/ARDS. Secondary efficacy variables will be the number of days without organ or system failure, in addition to the change in IL-6, IL-8, and TNF- α. Treatment will continue until the primary endpoint is reached, the patient discharged from the ICU or the maximum duration of 2 weeks, whichever occurs first. Patients will continued to be followed for a total of 28 days, or until discharged from the hospital, whichever occurs first.
Patients randomized, in a ratio of 1:1 to either Simvastatin 40 mg PO once daily or placebo tablet once daily in a format identical to Simvastatin.
The mortality from ALI/ARDS remains significant. In the absence of effective therapy, prophylaxis in patients at risk is an important goal to achieve. Therefore, if Simvastatin is found to decrease the incidence of ALI/ARDS, it would be a significant advance in the management of this deadly and frequent syndrome.
We have set up a Data Safety Monitoring Board (DSMB) that will closely monitor the progress of the trial (DSMB Charter attached to this application). Any adverse event will be reported directly to the institutional review board (IRB) and DSMB. All adverse events will be reported in the annual review of the protocol.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Oklahoma
-
Oklahoma City, Oklahoma, United States, 73104
- OU Medical Center
-
Oklahoma City, Oklahoma, United States, 73104
- Veterans Affairs Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
Placebo
|
Active Comparator: Simvastatin
Simvastatin 40 mg daily.
|
Simvastatin 40 mg daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of ARDS/ALI.
Time Frame: 4 weeks
|
4 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jean Keddissi, M.D., University of Oklahoma
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Respiratory Tract Diseases
- Respiration Disorders
- Lung Diseases
- Disease
- Infant, Newborn, Diseases
- Infant, Premature, Diseases
- Thoracic Injuries
- Syndrome
- Wounds and Injuries
- Respiratory Distress Syndrome
- Respiratory Distress Syndrome, Newborn
- Acute Lung Injury
- Lung Injury
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Simvastatin
Other Study ID Numbers
- 15377
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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