Trial of Antiseptic Irrigation for Pleural Infection (RINSE)
Empyema, Pleural
About this trial
This is an interventional treatment trial for Empyema, Pleural
Eligibility Criteria
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
Sites / Locations
- Alexandria University Faculty of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Antiseptic irrigation arm
Saline 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.
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.