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

NCT01623921 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2012-06-20

No results posted yet for this study

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

Interventions

DRUG

standard care treatment

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

DRUG

Celecoxib

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

DRUG

Rosuvastatin

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

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)

Sponsors & Collaborators

  • Tel-Aviv Sourasky Medical Center

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2013-08-31
Completion
2013-08-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01623921 on ClinicalTrials.gov