Empyema, Pleural
Conditions
Brief summary
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.
Interventions
Pleural irrigation with 2% povidone iodine
DRUGNormal saline
Pleural irrigation with normal saline
Sponsors
Alexandria University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage change in inflammatory markers before and after irrigation | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time in days to chest tube removal | At the time of chest tube removal (up to 6 weeks) | The time in days from the first irrigation to the chest tube removal |
| Total length of hospital stay in days | 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 |
| Percentage of radiological clearance between baseline and discharge chest X-rays | 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 |
| Incidence of medical treatment failure | 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) |
| Incidence of adverse events | 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 |
Countries
Egypt
Outcome results
None listed