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Statins and Selective Cyclooxygenase-2 Receptor Inhibitors in Blunt Chest Trauma

This study is not yet open for participant recruitment.
Verified June 2012 by Tel-Aviv Sourasky Medical Center
Sponsor:
Information provided by (Responsible Party):
Michal Roll PhD,MBA, Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01623921
First received: June 17, 2012
Last updated: June 19, 2012
Last verified: June 2012
History of Changes
  Purpose

Background: Lung contusion affects 17%-25% of adult blunt trauma patients, and is the leading cause of death from blunt thoracic injury. Statins are lipid-lowering drugs with recently suggested anti-inflammatory and antioxidant properties. Cyclo-oxygenase-2 (COX-2) is a key enzyme in the production of prostaglandins (PG), and evidence suggests that COX-2 plays an important role in the pathogenesis of acute lung injury (ALI).

Aims: The current study aims at evaluating the beneficial effects of statins and COX-2 receptor inhibitors on ALI elicited by blunt trauma to the chest.

Methods: After approval by the institutional ethics and a scientific committee, and obtaining informed consent , patients admitted to the emergency department (ED) due to blunt trauma with a diagnosis of lung contusion will be enrolled in the study.The effects of statins and COX 2 inhibitors on ALI will be assessed by recording clinical parameters and measuring inflammatory mediators levels in the serum and in the bronchoalveolar space.

Expected results: The investigators expect to find that the proposed treatment will be effective in reducing ALI burden. The investigators also suppose that using a combination of those drugs will synergistically potentiate their effect on ALI.


Condition Intervention
Blunt Chest Trauma
Acute Respiratory Distress Syndrome
 Drug: standard care treatment
Drug: Celecoxib
Drug: Rosuvastatin
Drug: Combined therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • 1. Signs of ALI, i.e., pneumonia, adult respiratory distress syndrome [ARDS] [ Time Frame: 3 days ] [ Designated as safety issue: No ]

    1. Signs of ALI, i.e., pneumonia, adult respiratory distress syndrome [ARDS] according to following criteria:

    1. Suspected or proven infection
    2. Hypoxemia: PaO2/FiO2is ≤300 mm HgBilateral infiltrates consistent with pulmonary edema
    3. Positive-pressure mechanical ventilation through an endotracheal tube
    4. No clinical evidence of left atrial hypertension to explain bilateral infiltrates
    5. Presence of at least three of the four SIRS criteria. If only two criteria are evidenced, one must be temperature or WBC


Estimated Enrollment: 100
Study Start Date: August 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
control
Group 1: control :(standard care treatment for individual lung contusion inluding analgesia with paracetamol/dypiron/ tramal)
 Drug: standard care treatment
Group 1: control :(standard care treatment for individual lung contusion inluding analgesia with paracetamol/dypiron/ tramal)
Active Comparator: Celecoxib
Group 2: Celecoxib 200 mg × 2/d+:(standard care treatment for individual lung contusion inluding analgesia with paracetamol/dypiron/ tramal)
 Drug: Celecoxib
Celecoxib 200 mg × 2/d+:(standard care treatment for individual lung contusion inluding analgesia with paracetamol/dypiron/ tramal)
Active Comparator: rosuvastatin
Group 3: Rosuvastatin 40mg × 1/d+:(standard care treatment for individual lung contusion inluding analgesia with paracetamol/dypiron/ tramal)
 Drug: Rosuvastatin
Rosuvastatin 40mg × 1/d+:(standard care treatment for individual lung contusion inluding analgesia with paracetamol/dypiron/ tramal)
Active Comparator: Combined therapy
Group 4: Combined therapy with Celecoxib 200 mg× 2/d + Rosuvastatin 40× 1/d +:(standard care treatment for individual lung contusion inluding analgesia with paracetamol/dypiron/ tramal)
 Drug: Combined therapy
Combined therapy with Celecoxib 200 mg× 2/d + Rosuvastatin 40× 1/d +:(standard care treatment for individual lung contusion inluding analgesia with paracetamol/dypiron/ tramal)

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients older than 18 years of age
  • Diagnosis of lung contusion by physical examination, chest xrays, history by the patient, accompanying persons or police.
  • Ability to understand and accept the trial procedures and to sign an informed consent form in accordance with national legislation.
  • Admission to ward

Exclusion Criteria:

  • Penetrating trauma
  • Current use of lipid-lowering therapy, use of non steroidal anti-inflammatory drugs.
  • Current use of postmenopausal hormone-replacement therapy
  • Evidence of hepatic dysfunction (an alanine aminotransferase level more than twice the upper limit of the normal range), a creatine kinase level more than three times the upper limit of the normal range.
  • Creatinine level higher than 2.0 mg/dl
  • Known uncontrolled hypertension (systolic blood pressure >190 mm Hg or diastolic blood pressure >100 mm Hg
  • History of uncontrolled hypothyroidism (thyroid-stimulating hormone level> 1.5 times the upper limit of the normal range)
  • Psychiatric disorders
  • Pregnancy
  • Known allergy or intolerance to one of the protocol drug
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01623921

Contacts
Contact: Avi A Weinbroum, MD 3-6973237 ext 972 draviw@tasmc.health.gov.il

Locations
Israel
Tel Aviv Sourasky Medical Center Not yet recruiting
Tel Aviv, Israel, 64239
Contact: Avi A Weinbroum, MD     3-6973237 ext 972     draviw@tasmc.health.gov.il    
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
  More Information

No publications provided

Responsible Party: Michal Roll PhD,MBA, Director, Division of Research & Development, Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT01623921     History of Changes
Other Study ID Numbers: TASMC-08-WAA-026911-TLV
Study First Received: June 17, 2012
Last Updated: June 19, 2012
Health Authority: Israel: Ethics Commission

Keywords provided by Tel-Aviv Sourasky Medical Center:
Lung
Contusion
Injury
Cyclooxygenase
Statin

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Thoracic Injuries
Wounds and Injuries
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury
Acetaminophen
Celecoxib
Rosuvastatin
Antipyretics
 Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents

ClinicalTrials.gov processed this record on June 18, 2013