Clinical trial NCT01623921: Statins and Selective Cyclooxygenase-2 Receptor Inhibitors in Blunt Chest Trauma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Blunt Chest Trauma
Acute Respiratory Distress Syndrome
Keywords: Lung
Contusion
Injury
Cyclooxygenase
Statin
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2012-06-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: 1. Signs of ALI, i.e., pneumonia, adult respiratory distress syndrome [ARDS]
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
Study officials:
References: