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

Acute Respiratory Distress Syndrome Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01623921
• Other study ID #: TASMC-08-WAA-026911-TLV
• Status: Not yet recruiting
• Phase: N/A
• First received: June 17, 2012
• Last updated: June 19, 2012
• Start date: August 2012
• Est. completion date: August 2013

Study information

• Verified date: June 2012
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Avi A Weinbroum, MD
• Phone: 3-6973237
• Email: draviw[@]tasmc.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Blunt Chest Trauma
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Thoracic Injuries

Intervention

Drug:
• standard care treatment
Group 1: control :(standard care treatment for individual lung contusion inluding analgesia with paracetamol/dypiron/ tramal)
• Celecoxib
Celecoxib 200 mg × 2/d+:(standard care treatment for individual lung contusion inluding analgesia with paracetamol/dypiron/ tramal)
• Rosuvastatin
Rosuvastatin 40mg × 1/d+:(standard care treatment for individual lung contusion inluding analgesia with paracetamol/dypiron/ tramal)
• 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)

Locations

Country	Name	City	State
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1. Signs of ALI, i.e., pneumonia, adult respiratory distress syndrome [ARDS]	1. Signs of ALI, i.e., pneumonia, adult respiratory distress syndrome [ARDS] according to following criteria: Suspected or proven infection; Hypoxemia: PaO2/FiO2is =300 mm HgBilateral infiltrates consistent with pulmonary edema; Positive-pressure mechanical ventilation through an endotracheal tube; No clinical evidence of left atrial hypertension to explain bilateral infiltrates; Presence of at least three of the four SIRS criteria. If only two criteria are evidenced, one must be temperature or WBC	3 days	No