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

Tel Aviv Sourasky Medical Center

Status: Unknown

Conditions: Acute Respiratory Distress Syndrome; Blunt Chest Trauma

Treatments: Drug: Combined therapy; Drug: standard care treatment; Drug: Rosuvastatin; Drug: Celecoxib

Study type: Interventional

Funder types: Other

Identifiers

NCT01623921

TASMC-08-WAA-026911-TLV

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 4 patient groups

control

Other group

Description:

Group 1: control :(standard care treatment for individual lung contusion inluding analgesia with paracetamol/dypiron/ tramal)

Treatment:

Drug: standard care treatment

Celecoxib

Active Comparator group

Description:

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

Treatment:

Drug: Celecoxib

rosuvastatin

Active Comparator group

Description:

Group 3: Rosuvastatin 40mg × 1/d+:(standard care treatment for individual lung contusion inluding analgesia with paracetamol/dypiron/ tramal)

Treatment:

Drug: Rosuvastatin

Combined therapy

Active Comparator group

Description:

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)

Treatment:

Drug: Combined therapy