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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Antiseptic irrigation arm | Experimental | 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. |
|
| Saline irrigation arm | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Povidone-iodine solution | Drug | Pleural irrigation with 2% povidone iodine |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Total length of hospital stay in days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alexandria University Faculty of Medicine | Alexandria | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31391221 | Background | 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. | |
| 24394842 | Background |
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These spreadsheet with individual participant data will be stored after trial conclusion with the principal investigator and will be accessible to other members of the study team. Request to access study data by other researchers will be expected via email and access will be granted by the principal investigator if the request is deemed reasonable.
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Data will be available for a minimum of five years after study conclusion
Request for access will be granted when reasonable reasons for request are given
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| ID | Term |
|---|---|
| D016724 | Empyema, Pleural |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D004653 | Empyema |
| D013492 | Suppuration |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Normal saline |
| Drug |
Pleural irrigation with normal saline |
|
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) |
| 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) |
| 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) |
| 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 |
| 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. |
| 34023322 | Background | 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. |
| 26022948 | Background | 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. |
| 33515303 | Background | 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. |
| 35039443 | Background | 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. |
| D010995 |
| Pleural Diseases |
| D012140 | Respiratory Tract Diseases |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |