Diaphragm Ultrasound to evaluate therapeutic effect of theophylline and anti-oxidant in ARDS - A Randomized Controlled Study
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- To evaluate the effects of the combination of theophylline and antioxidants as adjunctive therapy with the standard treatment in the outcome of mild-moderate ARDS patients by serial ultrasound imaging of diaphragm.
研究概览
简要总结
Patientswith mild-moderate ARDS grouped into ‘Experimental groups’ will receiveTheophylline 3-6 mg/kg oral and Vitamin-E 400 I.U/ day after informed consent,apart from the standard treatment. While,the ‘Control group’ won’t receive Theophylline and vitamin-E. Throughmonitoring of HR, BP, ECG, SpO2, FiO2, ventilator settings(if any), and urine output will be done. Sonographicexamination of the bilateral hemidiaphragm includes measurement of muscle sizeto evaluate for potential atrophy, analysis of muscle contraction, andthickening ratios at maximum inspiration and end-expiration. Pertinent findingssuch as the presence of pleural effusions, ascites or hepatomegaly should bereported.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Clinical History and investigations that support diagnosis of mild-moderate ARDS.
排除标准
- •Severe ARDS
- •Pregnancy
- •Severe traumatic brain injury
- •Phrenic nerve injury
- •Hepatic dysfunction
- •Abdominal Surgeries
- •Renal failure on RRT 9.Long term use of Steroids.
结局指标
主要结局
To evaluate the effects of the combination of theophylline and antioxidants as adjunctive therapy with the standard treatment in the outcome of mild-moderate ARDS patients by serial ultrasound imaging of diaphragm.
时间窗: Day 1,2,3,4,5,6,7
次要结局
- Determine the length of ICU stay(Day 1,2,3,4,5)