CTRI/2024/07/071438尚未招募4 期
Dexamethasone in severe Community-Acquired Pneumonia in children: a randomised controlled trial
Siddannagoud salotagi1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年8月11日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- All-cause mortality at 28 days
研究概览
简要总结
- Pneumonia is the single greatest cause of death in children worldwide. Nearly 2 million children younger than 5 years die each year of pneumonia, representing nearly 20-24% of all deaths in children within this age group. With the widespread use of antibiotics also, there is considerable mortality among children. Increasing evidence supports a central role of the immune system in sepsis, but the current view of how sepsis affects immunity, and vice versa, is still rudimentary. Understanding how immunological alterations predispose to sepsis, key aspects of the immunopathological events during sepsis, and the long-term consequences of sepsis on a patient’s immunity are particularly important. . Cytokine storms during infections can lead to poor outcomes. It is been hypothesized that CAP patients would have different cytokine profiles according to their different causes, severity, and outcomes. Studies have shown that corticosteroids reduce proinflammatory cytokines in pneumonia and may improve clinical outcomes in adults. Hence we are conducting this study.Dexamethasone in severe Community-Acquired Pneumonia in children – a randomized controlled trial: DeCAP trial, to look for whether it reduces the mortality. In this study Patients in the intervention group will receive dexamethasone at 0.1mg/kg/dose every 8 hours for 5 days. The intravenous route will be used. Patients of the control group will receive an intravenous placebo (Normal saline) by an intravenous route at the same frequency. Dexamethasone or placebo will be given in a double-blind fashion for 5 days. Patients will be monitored any anaphylaxis reaction, features of fluid retention, Acid and electrolyte disturbances (Hypokalaemia, Hypernatremia, Metabolic alkalosis), Hyperglycaemia, Hypertension, new infections after starting dexamethasone till first 5 days. After 5 days patients will be monitored for neutrophilia, lymphopenia and new onset infections during the hospital stay or till primary outcome. In case of discharge after 5 days patient will be followed physically or telephonically to look for primary outcome and new infections. The primary and secondary outcome will be recorded and followed up for next 28 days in both the groups. Patients will also be followed till 90 days either physically or telephonically.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 1.00 Month(s) 至 14.00 Year(s)（—）
- 性别
- All
入选标准
- •Children with severe community-acquired pneumonia.
排除标准
- •Child already on steroid therapy ( Any condition requiring 20 mg of prednisone equivalent/day or more for greater than 14 days over the last 3 months)
- •Known Immunodeficiency
- •Comorbidities Comorbidities: Cystic fibrosis, malignancy
- •Presence of pre-existing medical condition that is irreversible and expected to be fatal within 3 months
- •GI bleeding requiring transfusion or requiring withholding of feed for more than 24 hours
- •Active tuberculosis.
结局指标
主要结局
All-cause mortality at 28 days
时间窗: All-cause mortality at 28 days
次要结局
- Duration of mechanical ventilation(Total duration of mechanical ventilation)
- All-cause mortality at day 90
- New onset HAI during hospitalization(IPD days)
- Duration of oxygen support(Total Duration of oxygen support)
- Duration of ICU hospitalization, and hospital stay(total length of stay)
- Rates of septic shock, and hyperferritinemia, by day 28(28 days)
研究者
Siddannagoud Salotagi
AIIMS Raipur
研究点 (1)
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