Trial of Antiseptic Irrigation for Pleural Infection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-19

Study Completion Date

2024-05-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Empyema, Pleural

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Povidone-iodine solution

Intervention Type DRUG

Pleural irrigation with 2% povidone iodine

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.

Group Type ACTIVE_COMPARATOR

Normal saline

Intervention Type DRUG

Pleural irrigation with normal saline

Interventions

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Povidone-iodine solution

Pleural irrigation with 2% povidone iodine

Intervention Type DRUG

Normal saline

Pleural irrigation with normal saline

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No