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

• Status: Unknown status
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tel-Aviv Sourasky Medical Center
• Treatments: Acetaminophen; Celecoxib; Rosuvastatin Calcium

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