Statins and Selective Cyclooxygenase-2 Receptor Inhibitors in Blunt Chest Trauma
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 1. Signs of ALI, i.e., pneumonia, adult respiratory distress syndrome [ARDS]
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
control
Group 1: control :(standard care treatment for individual lung contusion inluding analgesia with paracetamol/dypiron/ tramal)
干预措施: standard care treatment (Drug)
Celecoxib
Group 2: Celecoxib 200 mg × 2/d+:(standard care treatment for individual lung contusion inluding analgesia with paracetamol/dypiron/ tramal)
干预措施: Celecoxib (Drug)
rosuvastatin
Group 3: Rosuvastatin 40mg × 1/d+:(standard care treatment for individual lung contusion inluding analgesia with paracetamol/dypiron/ tramal)
干预措施: Rosuvastatin (Drug)
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)
干预措施: Combined therapy (Drug)
结局指标
主要结局
1. Signs of ALI, i.e., pneumonia, adult respiratory distress syndrome [ARDS]
时间窗: 3 days
1. Signs of ALI, i.e., pneumonia, adult respiratory distress syndrome \[ARDS\] according to following criteria: 1. Suspected or proven infection 2. Hypoxemia: PaO2/FiO2is ≤300 mm HgBilateral infiltrates consistent with pulmonary edema 3. Positive-pressure mechanical ventilation through an endotracheal tube 4. No clinical evidence of left atrial hypertension to explain bilateral infiltrates 5. Presence of at least three of the four SIRS criteria. If only two criteria are evidenced, one must be temperature or WBC
次要结局
未报告次要终点
研究者
Michal Roll PhD,MBA
Director, Division of Research & Development
Tel-Aviv Sourasky Medical Center