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WithdrawnNCT01195428Updated Jan 7, 2014

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

An interventional study of Simvastatin and Placebo in Adult Respiratory Distress Syndrome and Acute Lung Injury, sponsored by University of Oklahoma. Withdrawn at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-01-07.

Sponsored by University of Oklahoma · Not applicable, Interventional, and Prevention

Why this study was withdrawn
Minimal enrollment
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Adult Respiratory Distress Syndrome
  • Acute Lung Injury
03

In context

Respiratory Distress Syndrome

1,619 studies on the registry are indexed under Respiratory Distress Syndrome; 319 are open to participants now.

Browse Respiratory Distress Syndrome studies →

Lead sponsor

University of Oklahoma is the lead sponsor of 432 studies on the registry; 100 are open to participants now.

Of its 42 completed or terminated interventional studies of FDA-regulated products, 16 (38%) have results posted.

Browse University of Oklahoma studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • Active comparator
    Simvastatin

    Simvastatin 40 mg daily.

    Drug: Simvastatin

  • Placebo comparator
    Placebo

    Placebo

    Drug: Placebo

Interventions

  • DrugSimvastatin

    Simvastatin 40 mg daily

  • DrugPlacebo

    Placebo

06

What researchers measure

Primary outcomes

  1. Incidence of ARDS/ALI.

    Time frame: 4 weeks

07

Study locations

2 sites
  • OU Medical Center
    Oklahoma City, Oklahoma 73104, United States
  • Veterans Affairs Medical Center
    Oklahoma City, Oklahoma 73104, United States
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 2010, a primary completion of Oct 2011 and a completion of Oct 2011. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 2, 2010
First posted
Sep 6, 2010
Start
Oct 2010
Primary completionActual
Oct 2011
CompletionActual
Oct 2011
Last update
Jan 7, 2014
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 7, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01195428
Lead sponsor
University of Oklahoma
Collaborators
US Department of Veterans Affairs
Responsible party
Sponsor
First posted
Sep 6, 2010
Start date
Oct 2010
Primary completion
Oct 2011
Completion
Oct 2011
Last update
Jan 7, 2014

Study contacts

Jean Keddissi, M.D.
principal investigator · University of Oklahoma
Gary T. Kinasewitz, MD
principal investigator · University of Oklahoma

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.

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