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临床试验/CTRI/2025/12/099899
CTRI/2025/12/099899招募中2 期

Comparative Efficacy and Safety of Hydrocortisone vs Dexamethasone in Severe Community Acquired Pneumonia: A Randomized Controlled Trial

AIIMS New Delhi1 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2026年1月14日最近更新:

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

发起方
AIIMS New Delhi
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Mahima Reddy

AIIMS New Delhi

研究点 (1)

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