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CTRI Number  CTRI/2024/02/063002 [Registered on: 21/02/2024] Trial Registered Prospectively
Last Modified On: 25/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Process of Care Changes
Other (Specify) [Intervention- Large volume saline irrigation via chest tube three Q8h ]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Large volume instillation of normal saline solution within the pleura in cases of infection of the pleural space. 
Scientific Title of Study   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. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shakti Kumar Bal 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences, Bhubaneswar 
Address  Dr Shakti Kumar Bal, Associate Professor, Room number- 148,Pulmonary Medicine and Critical Care OPD,1st floor, OPD block, All India Institute of Medical Sciences, Bhubaneswar

Khordha
ORISSA
751019
India 
Phone  9345708801  
Fax    
Email  leeshakti@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Siddarth Singh 
Designation  Senior Resident (academic) 
Affiliation  All India Institute of Medical Sciences, Bhubaneswar 
Address  Dr Siddarth Singh Senior Resident (Academic) H-4 ward (Pulmonary Medicine Ward) H-block, 4th floor All India Institute of Medical Sciences, Bhubaneswar

Khordha
ORISSA
751019
India 
Phone  8728846666  
Fax    
Email  drsiddarthsingh@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Siddarth Singh 
Designation  Senior Resident (academic) 
Affiliation  All India Institute of Medical Sciences, Bhubaneswar 
Address  Dr Siddarth Singh Senior Resident (Academic) H-4 ward (Pulmonary Medicine Ward) H-block, 4th floor All India Institute of Medical Sciences, Bhubaneswar

Khordha
ORISSA
751019
India 
Phone  8728846666  
Fax    
Email  drsiddarthsingh@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Bhubaneswar 
 
Primary Sponsor  
Name  Dr Shakti Kumar Bal 
Address  Dr Shakti Kumar Bal, Associate Professor, Department of Pulmonary Medicine and Critical Care, All India Institute of Medical Sciences, Bhubaneswar, Telephone Number: 9345708801, email id: leeshakti@gmail.com  
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Dr Siddarth Singh  Dr Siddarth Singh Senior Resident (Academic) Department of Pulmonary Medicine and Critical Care All India Institute of Medical Sciences, Bhubaneswar Telephone number: 8288822181 Email Id: drsiddarthsingh@gmail.com  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Siddarth Singh  All India Institute of Medical Sciences, Bhubaneswar  Department of Pulmonary Medicine and Critical Care, Pulmonary Medicine ward, 4th floor, H block All India Institute of Medical Sciences, Bhubaneswar
Khordha
ORISSA 		 8728846666

drsiddarthsingh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee All India Institute of Medical Sciences, Bhubaneswar.   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J869||Pyothorax without fistula,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Saline Irrigation of the pleura  Large volume saline irrigation via chest tube three times a day 
Comparator Agent  Standard of care  Standard of care using 30 ml NS which will be flushed via 50 ml syringe 6 hourly to keep the tube patent for regular drainage of pleural effusion. 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  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 
 
ExclusionCriteria 
Details  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 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Proportions of patient needing surgery at 30 days in each arm  Baseline, day 3, day 7, day 14, and day 30. 
 
Secondary Outcome  
Outcome  TimePoints 
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 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   28/02/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Closed to Recruitment of Participants 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [leeshakti@gmail.com].

  6. For how long will this data be available start date provided 01-06-2026 and end date provided 01-06-2030?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

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.

 
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