Clinical trial NCT05546762: Trial of Antiseptic Irrigation for Pleural Infection
Official title: IrRigation of the INfected Pleural Space With antiSEptic Solution (RINSE) - a Proof of Concept Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Empyema, Pleural
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2022-09-21
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percentage change in inflammatory markers before and after irrigation
timeFrame: 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 outcomes:
measure: Time in days to chest tube removal
timeFrame: At the time of chest tube removal (up to 6 weeks)
measure: Total length of hospital stay in days
timeFrame: At the point of deciding a patient is medically fit for discharge (assessed up to 6 weeks)
measure: Percentage of radiological clearance between baseline and discharge chest X-rays
timeFrame: baseline and discharge (up to week 6)
measure: Incidence of medical treatment failure
timeFrame: At discharge from the hospital or referral to another department (assessed up to week 6)
measure: Incidence of adverse events
timeFrame: Adverse events will be recognised if they appear within 6 hours of a given irrigation procedure
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria University Faculty of Medicine
Study officials:
References:
citation: Cargill TN, Hassan M, Corcoran JP, Harriss E, Asciak R, Mercer RM, McCracken DJ, Bedawi EO, Rahman NM. A systematic review of comorbidities and outcomes of adult patients with pleural infection. Eur Respir J. 2019 Oct 1;54(3):1900541. doi: 10.1183/13993003.00541-2019. Print 2019 Sep.
citation: Sogaard M, Nielsen RB, Norgaard M, Kornum JB, Schonheyder HC, Thomsen RW. Incidence, length of stay, and prognosis of hospitalized patients with pleural empyema: a 15-year Danish nationwide cohort study. Chest. 2014 Jan;145(1):189-192. doi: 10.1378/chest.13-1912. No abstract available.
citation: Mummadi SR, Stoller JK, Lopez R, Kailasam K, Gillespie CT, Hahn PY. Epidemiology of Adult Pleural Disease in the United States. Chest. 2021 Oct;160(4):1534-1551. doi: 10.1016/j.chest.2021.05.026. Epub 2021 May 20.
citation: Hooper CE, Edey AJ, Wallis A, Clive AO, Morley A, White P, Medford AR, Harvey JE, Darby M, Zahan-Evans N, Maskell NA. Pleural irrigation trial (PIT): a randomised controlled trial of pleural irrigation with normal saline versus standard care in patients with pleural infection. Eur Respir J. 2015 Aug;46(2):456-63. doi: 10.1183/09031936.00147214. Epub 2015 May 28.
citation: Muthu V, Dhooria S, Sehgal IS, Prasad KT, Aggarwal AN, Agarwal R. Iodopovidone pleurodesis for malignant pleural effusions: an updated systematic review and meta-analysis. Support Care Cancer. 2021 Aug;29(8):4733-4742. doi: 10.1007/s00520-021-06004-3. Epub 2021 Jan 30.
citation: Elhoffy A, Amin A, Sadaka AS, Hassan M. Management of a complex thoracic infection, one compartment at a time. Thorax. 2022 Apr;77(4):417-419. doi: 10.1136/thoraxjnl-2021-218475. Epub 2022 Jan 17. No abstract available.