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Large volume instillation of normal saline solution within the pleura in cases of infection of the pleural space.

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.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/02/063002
Enrollment
64
Registered
2024-02-21
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J869- Pyothorax without fistula

Interventions

Intervention1: Saline Irrigation of the pleura: Large volume saline irrigation via chest tube three times a day Control Intervention1: Standard of care to keep the chest tube patent: Standard Flushing

Sponsors

Dr Shakti Kumar Bal
Lead Sponsor
Dr Siddarth Singh
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
1.Proportions of patient needing surgery at 30 days in each armTimepoint: Baseline, day 3, day 7, day 14, and day 30.

Secondary

MeasureTime frame
Clinical and radiological improvement at the end of interventionTimepoint: 30 days;Length of Hospital StayTimepoint: 30 days;Change in the clinical fraility index, Fi-LAB and RAPID score at end of 1 monthTimepoint: 30 days;Reduction in inflammatory markers- CRP, neutrophilic Leucocytosis at end of treatmentTimepoint: 30 days;Additional pleural manoeuvres required like additional chest drain or additionall thoracoscopyTimepoint: 30 days

Countries

India

Contacts

Public ContactDr Siddarth Singh

All India Institute of Medical Sciences, Bhubaneswar

drsiddarthsingh@gmail.com8728846666

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026