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

NCT ID: NCT01623921

Last Updated: 2012-06-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2013-08-31

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.

Conditions

Blunt Chest Trauma; Acute Respiratory Distress Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

control

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

Group Type: OTHER

standard care treatment

Intervention Type: DRUG

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

Celecoxib

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

Group Type: ACTIVE_COMPARATOR

Celecoxib

Intervention Type: DRUG

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

rosuvastatin

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

Group Type: ACTIVE_COMPARATOR

Rosuvastatin

Intervention Type: DRUG

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

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)

Group Type: ACTIVE_COMPARATOR

Combined therapy

Intervention Type: DRUG

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)

Interventions

standard care treatment

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

Intervention Type: DRUG

Celecoxib

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

Intervention Type: DRUG

Rosuvastatin

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

Intervention Type: 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)

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Michal Roll PhD,MBA

Director, Division of Research & Development

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tel Aviv Sourasky Medical Center

Tel Aviv, , Israel

Countries

Israel

Central Contacts

Avi A Weinbroum, MD

Role: CONTACT

draviw@tasmc.health.gov.il

3-6973237 ext. 972

Facility Contacts

Avi A Weinbroum, MD

Role: primary

draviw@tasmc.health.gov.il

3-6973237 ext. 972

Other Identifiers

TASMC-08-WAA-026911-TLV

Identifier Type: -

Identifier Source: org_study_id