Trial of Antiseptic Irrigation for Pleural Infection

Empyema, Pleural Clinical Trial

— RINSE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05546762
• Other study ID #: 02/24/09/2022
• Status: Recruiting
• Phase: Phase 2
• Start date: September 19, 2022
• Est. completion date: May 1, 2024

Study information

• Verified date: September 2022
• Source: Alexandria University
• Contact: Maged Hassan, PhD
• Phone: +447960357965
• Email: maged.mahmoud[@]alexmed.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: May 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Empyema
• Empyema, Pleural

Intervention

Drug:
• Povidone-iodine solution
Pleural irrigation with 2% povidone iodine
• Normal saline
Pleural irrigation with normal saline

Locations

Country	Name	City	State
Egypt	Alexandria University Faculty of Medicine	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

References & Publications (6)

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). pii: 1900541. doi: 10.1183/13993003.00541-2019. Print 2019 Sep. — View 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. — View 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. — View 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. — View 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. — View Citation

Søgaard M, Nielsen RB, Nørgaard M, Kornum JB, Schønheyder 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage change in inflammatory markers before and after 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	Time in days to chest tube removal	The time in days from the first irrigation to the chest tube removal	At the time of chest tube removal (up to 6 weeks)
Secondary	Total length of hospital stay in days	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)
Secondary	Percentage of radiological clearance between baseline and discharge chest X-rays	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)
Secondary	Incidence of medical treatment failure	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)
Secondary	Incidence of adverse events	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