Comparing the Efficacy of Large Volume Pleural Irrigation Versus Conventional Management in Pleural Infection Using Small-Bore Intercostal Chest Tube in Preventing Surgery: A Randomized Controlled Trial.
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- 1. Proportions of patient needing surgery at 30 days in each arm
研究概览
简要总结
This study is a randomized, single blinded, parallel group, single centre trial comparing the efficacy of large volume saline irrigation to the standard of care in patients with pleural infection that will be conducted in All India Institute of Medical Sciences, Bhubaneswar. The primary outcome is proportion of patients needing surgery at 30 days in each arm. The secondary outcome is clinical and radiological improvement at the end of intervention, length of hospital stays, change in frailty index, Fi-LAB and Rapid score at end of 1 month, reduction in inflammatory marker at end of treatment and the need of additional pleural maneuvers required like additional chest drain or additional thoracoscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 15.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •adults male and female with complicated parapneumonic pleural effusion complicated parapneumonic pleural effusion defined as pleural effusion that is macroscopically purulent, or positive on routine aerobic culture or positive on gram stain or positive AFB/CBNAAT or pleural fluid that has pH less than 7.2 or pleural fluid that has glucose less than 72mg/dl or pleural fluid LDH more than 900 IU/L or loculated pleural effusion.
排除标准
- •Age less than 15 years or previous thoracic surgery or chest tube insertion done more than 72 hours ago or chest tube size more than 16 french or drainage not safe due to organised pleural effusion or fluid not amenable to safe intervention or pregnancy or infected malignant pleural effusion or presence of air leak more than grade 2.
结局指标
主要结局
1. Proportions of patient needing surgery at 30 days in each arm
时间窗: Baseline, day 3, day 7, day 14, and day 30.
次要结局
- Clinical and radiological improvement at the end of intervention(30 days)
- Length of Hospital Stay(30 days)
- Change in the clinical fraility index, Fi-LAB and RAPID score at end of 1 month(30 days)
- Reduction in inflammatory markers- CRP, neutrophilic Leucocytosis at end of treatment(30 days)
- Additional pleural manoeuvres required like additional chest drain or additionall thoracoscopy(30 days)
研究者
Dr Shakti Kumar Bal
All India Institute of Medical Sciences, Bhubaneswar