The effect of intravenous magnesium sulphate in acute exacerbation of chronic obstructive pulmonary disease patient requiring non-invasive ventilation support: a randomized clinical trial
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- 1. Respiratory rate improvement
研究概览
简要总结
The precise role of intravenous magnesium sulphate in severe COPD exacerbations remains unclear. While its efficacy has been established in milder cases, its impact on severe exacerbations is yet to be distinctly defined. This study aims to find efficacy of intravenous magnesium sulphate in acute severe COPD exacerbations requiring Non-Invasive Ventilation (NIV) support.
Patient of acute exacerbation of COPD requiring NIV support will be recruited. Both groups will receive initial Lev salbutamol 1.25mg plus Ipratropium bromide 500 mcg nebulization 3 times in one hour duration. In addition, the experimental group will receive 2 gm intravenous magnesium sulphate in 100ml normal saline over 30 minute and control group will receive only 100 ml normal saline (placebo) over 30 min. ABG analysis will be done at 0, 1 hr, 4hr, 12hr, 24hr, after start of NIV in each group.Clinical parameters like respiratory rate, heart rate, SpO2, dyspnea severity score will also be monitored in same time interval as above. Primary objectives are respiratory rate and arterial pH and pCO2 improvement. Secondary Objectives are a) NIV failure rate and rate endotracheal intubation b) duration of NIV requirement in both group c) length of hospital stay.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •All patient of AECOPD with following criteria’s a)pH less than 7.35, pCO2 more than 45 mm hg.
- •or b)persistent hypoxemia despite supplemental oxygen therapy.
- •[persistent hypoxemia that is patient not able to maintain more than 88% after 15 min of NRBM (15L per minute O2) or c)severe dyspnea with clinical signs suggestive of respiratory muscle fatigue, increased of work of breathing or both, such as use of respiratory accessory muscles paradoxical motion of the abdomen or retraction of intercostal spaces.
排除标准
- •a)Patient with contraindication for use of mgso4 { hypersensitivity ,diabetic coma ,heart block, myocardial damage , dyselectrolytemia such as hypomagnesemia ,hypercalcemia) b) use of I.V. mgso4 in past 24 hours c)using medication that contain magnesium d)pregnant women e) pneumonia, pleural or pericardial effusion, pneumothorax, heart failure renal failure, sepsis.
- •f) Haemodynamically unstable patient g) Patient requiring immediate endotracheal intubation.
- •h) Uncooperative patient i) Did not consent to participate.
结局指标
主要结局
1. Respiratory rate improvement
时间窗: baseline, 1 hr,4hr,12hr,24hr
2. ABG parameters: arterial pH and pCO2 improvement.
时间窗: baseline, 1 hr,4hr,12hr,24hr
次要结局
- a)NIV failure rate and rate endotracheal intubation.
研究者
SADANANDA BARIK
AIIMS BHUBANESWAR