Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control | Other | Group 1: control :(standard care treatment for individual lung contusion inluding analgesia with paracetamol/dypiron/ tramal) |
|
| Celecoxib | Active Comparator | Group 2: Celecoxib 200 mg × 2/d+:(standard care treatment for individual lung contusion inluding analgesia with paracetamol/dypiron/ tramal) |
|
| rosuvastatin | Active Comparator | Group 3: Rosuvastatin 40mg × 1/d+:(standard care treatment for individual lung contusion inluding analgesia with paracetamol/dypiron/ tramal) |
|
| Combined therapy | Active Comparator | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| standard care treatment | Drug | Group 1: control :(standard care treatment for individual lung contusion inluding analgesia with paracetamol/dypiron/ tramal) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 3 days |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Avi A Weinbroum, MD | Contact | 3-6973237 | 972 | draviw@tasmc.health.gov.il |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tel Aviv Sourasky Medical Center | Tel Aviv | 64239 | Israel |
Not provided
| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| D003288 | Contusions |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D014949 | Wounds, Nonpenetrating |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068579 | Celecoxib |
| D000068718 | Rosuvastatin Calcium |
| D011616 | Psychotherapy, Multiple |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Celecoxib | Drug | Celecoxib 200 mg × 2/d+:(standard care treatment for individual lung contusion inluding analgesia with paracetamol/dypiron/ tramal) |
|
| Rosuvastatin | Drug | Rosuvastatin 40mg × 1/d+:(standard care treatment for individual lung contusion inluding analgesia with paracetamol/dypiron/ tramal) |
|
| Combined therapy | 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) |
|
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D011743 | Pyrimidines |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |