Trial of Antiseptic Irrigation for Pleural Infection (RINSE)

September 26, 2022 updated by: Maged Hassan, Alexandria University

IrRigation of the INfected Pleural Space With antiSEptic Solution (RINSE) - a Proof of Concept Study

Pleural antiseptic irrigation (PAI) is used in conjunction with open drainage for treating adults with chronic post-thoracotomy empyema. The antiseptic povidone-iodine can safely be instilled into the pleural cavity for the purpose of pleurodesis and has recently been described for pleural irrigation in the acute management of paediatric pleural infection with good outcomes. A recent case report demonstrated the safe use of povidone-iodine pleural irrigation in a patient with complex pleural empyema with successful medical management. In a previous pilot study, antiseptic irrigation led to less referral to surgery and shorter length of hospital stay in comparison to no irrigation.

This study aims to investigate the effect of antiseptic pleural irrigation (using povidone iodine) on the inflammatory response in adults patients with pleural infection in comparison to irrigation with normal saline alone. A reduction in the systemic inflammatory response can be inferred to correlate with reduction in the infection burden in the pleural space.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

44

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults (18 year-old or more)
  • Pleural infection diagnosed by: the presence of pus in the pleural space, OR any of the following in the setting of acute lower-respiratory tract infection symptoms: pleural fluid PH<7.2 or pleural fluid glucose <40 mg/dL, positive gram stain or culture from pleural fluid
  • Predominantly unilocular pleural collection treated with chest tube drainage
  • Acute response at presentation as evidenced by fever (>37.80C) and/or blood leucocytosis (>11X103/mm3) and/or high serum C-reactive protein, CRP (>50 mg/L)

Exclusion Criteria:

  • Known or suspected thyroid disease
  • Allergy to iodine
  • Persistent large collection on follow-up imaging 24-48 post tube insertion that is deemed to require additional interventions (e.g., another drainage procedure, intrapleural fibrinolytic)
  • Evidence or suspicion of broncho-pleural fistula (suspected when there is air-fluid level without previous intervention, or if the participant is coughing large volume of purulent sputum that is physically similar to drained pleural fluid)
  • Tuberculous, post-operative or post-haemothorax pleural infections

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Antiseptic irrigation arm
250 ml solution of 2% povidone-iodine (i.e. 50 ml betadine in 200 ml saline) will be attached to the chest tube via a giving set and a 3-way tap and irrigated into the pleural space with gravity. The chest tube will be clamped for 10-20 minutes after irrigation and then will be unclamped and left to drain freely. The first dose will be applied 24-48 hours after tube insertion. This will be repeated every 12 hours for a total of four to six applications.
Drug: Povidone-iodine solution
Pleural irrigation with 2% povidone iodine
Active Comparator: Saline irrigation arm
250 ml solution of normal saline will be attached to the chest tube via a giving set and a 3-way tap and irrigated into the pleural space with gravity. The chest tube will be clamped for 10-20 minutes after irrigation and then will be unclamped and left to drain freely. The first dose will be applied 24-48 hours after tube insertion. This will be repeated every 12 hours for a total of four to six applications.
Drug: Normal saline
Pleural irrigation with normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage change in inflammatory markers before and after irrigation
Time Frame: Initial levels to be measured 12 to 48 hours post tube insertion and follow up levels 12 to 24 hours post last dose of irrigation
The percentage by which inflammatory marker (CRP and/or procalcitonin) decrease after completing all irrigations in comparison to the pre-irrigation inflammatory markers level
Initial levels to be measured 12 to 48 hours post tube insertion and follow up levels 12 to 24 hours post last dose of irrigation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time in days to chest tube removal
Time Frame: At the time of chest tube removal (up to 6 weeks)
The time in days from the first irrigation to the chest tube removal
At the time of chest tube removal (up to 6 weeks)
Total length of hospital stay in days
Time Frame: At the point of deciding a patient is medically fit for discharge (assessed up to 6 weeks)
Duration of hospital stay from admission until a patient is declared medically fit for discharge
At the point of deciding a patient is medically fit for discharge (assessed up to 6 weeks)
Percentage of radiological clearance between baseline and discharge chest X-rays
Time Frame: baseline and discharge (up to week 6)
Percentage of radiological clearance of pleural abnormalities between baseline and discharge chest X-rays using a computer software
baseline and discharge (up to week 6)
Incidence of medical treatment failure
Time Frame: At discharge from the hospital or referral to another department (assessed up to week 6)
Number of patients who fail medical treatment (referral to surgery, further pleural procedures or death)
At discharge from the hospital or referral to another department (assessed up to week 6)
Incidence of adverse events
Time Frame: Adverse events will be recognised if they appear within 6 hours of a given irrigation procedure
Number of patients with different types of adverse events
Adverse events will be recognised if they appear within 6 hours of a given irrigation procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexandria University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 19, 2022

Primary Completion (Anticipated)

April 1, 2024

Study Completion (Anticipated)

May 1, 2024

Study Registration Dates

First Submitted

September 11, 2022

First Submitted That Met QC Criteria

September 15, 2022

First Posted (Actual)

September 21, 2022

Study Record Updates

Last Update Posted (Actual)

September 27, 2022

Last Update Submitted That Met QC Criteria

September 26, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02/24/09/2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

These spreadsheet with individual participant data will be stored after trial conclusion with the principal investigator and will be accessible to other members of the study team. Request to access study data by other researchers will be expected via email and access will be granted by the principal investigator if the request is deemed reasonable.

IPD Sharing Time Frame

Data will be available for a minimum of five years after study conclusion

IPD Sharing Access Criteria

Request for access will be granted when reasonable reasons for request are given

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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