arge volume instillation of normal saline solution within the pleura in cases of infection of the pleural space.
- Conditions
- Health Condition 1: J869- Pyothorax without fistula
- Registration Number
- CTRI/2024/02/063002
- Lead Sponsor
- Dr Shakti Kumar Bal
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Proportions of patient needing surgery at 30 days in each armTimepoint: Baseline, day 3, day 7, day 14, and day 30.
- Secondary Outcome Measures
Name Time Method Additional pleural manoeuvres required like additional chest drain or additionall thoracoscopyTimepoint: 30 days;Change in the clinical fraility index, Fi-LAB and RAPID score at end of 1 monthTimepoint: 30 days;Clinical and radiological improvement at the end of interventionTimepoint: 30 days;Length of Hospital StayTimepoint: 30 days;Reduction in inflammatory markers- CRP, neutrophilic Leucocytosis at end of treatmentTimepoint: 30 days