Comparative Efficacy and Safety of Hydrocortisone vs Dexamethasone in Severe Community Acquired Pneumonia: A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 126
- 试验地点
- 1
研究概览
简要总结
This is a Prospective, Open label, Randomised Control Trial of Parallel Group to compare Efficacy and Safety of Hydrocortisone vs Dexamethasone in Patients with Severe Community Acquired Pneumonia. Patients diagnosed with Severe Community Acquired Pneumonia will be included in this study after excluding patients meeting exclusion criteria. Patients will be randomized into 2 arms using computer generated randomization sequence and allocation concealment will be done through SNOSE technique. All patients who will be recruited in the study will be explained about the study , given a patient information sheet and they will sign a consent form provided both in hindi and english.
Patients in the intervention arm will recieve Dexamethasone and those in control arm will recieve Hydrocortisone. Our primary objective is to compare the length of hospital stay between the 2 groups. Secondary objectives are to compare the all cause mortality on day 28 and day 60, the requirement and duration of requirement of vasopressors , non invasive ventilation and mechanical ventilation and to compare the adverse effects in terms of hyperglycemia ,hospital acquired infections ,Gastro intestinal bleeding and dyselectrolytemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 85.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients with Severe Community Acquired Pneumonia as per Infectious Disease Society Of America Guidelines.
排除标准
- •1 Viral pneumonia 2 Chronic use of steroids 3 Pregnant women 4 Patients who have DNR order 5 Viral hepatitis 6 Active Herpes infection 7 Active TB 8 Fungal Pneumonia 9 Myelosupression 10 Active upper GI Bleeding 11 Diabetic Ketoacidosis 12 Hyperosmolar Hyperglycemic state 13 Hypersensitivity to steroids.
研究者
Dr Mahima Reddy
AIIMS New Delhi
