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

NCT01195428 | Withdrawn DMC

• 1 other identifier: 15377
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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 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.

Conditions

Adult Respiratory Distress Syndrome; Acute Lung Injury

Outcome Measures

Primary Outcomes (1)

• Incidence of ARDS/ALI.

  4 weeks

Study Arms (2)

Simvastatin

ACTIVE COMPARATOR

Simvastatin 40 mg daily.

Drug: Simvastatin

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Simvastatin DRUG

Simvastatin 40 mg daily

Simvastatin

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• University of Oklahoma: lead
• US Department of Veterans Affairs: collaborator

Study Sites (2)

OU Medical Center

Oklahoma City, Oklahoma, 73104, United States

Location

Veterans Affairs Medical Center

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome; Acute Lung Injury

Interventions

Simvastatin

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Lung Injury

Intervention Hierarchy (Ancestors)

Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Jean Keddissi, M.D.

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

• Gary T. Kinasewitz, MD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2010
• First Posted: September 6, 2010
• Study Start: October 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: January 7, 2014

Record last verified: 2014-01

Locations

US (2)