Trial of Antiseptic Irrigation for Pleural Infection

NCT05546762 | Unknown Phase 2

• 1 other identifier: 02/24/09/2022
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Empyema, Pleural

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Time in days to chest tube removal

  At the time of chest tube removal (up to 6 weeks)

• Total length of hospital stay in days

  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

  baseline and discharge (up to week 6)

• Incidence of medical treatment failure

  At discharge from the hospital or referral to another department (assessed up to week 6)

• Incidence of adverse events

  Adverse events will be recognised if they appear within 6 hours of a given irrigation procedure

Study Arms (2)

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.

Drug: Povidone-iodine solution

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.

Drug: Normal saline

Interventions

Povidone-iodine solution DRUG

Pleural irrigation with 2% povidone iodine

Antiseptic irrigation arm

Normal saline DRUG

Pleural irrigation with normal saline

Saline irrigation arm

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Alexandria University Faculty of Medicine

Alexandria, Egypt

RECRUITING

Related 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):1900541. doi: 10.1183/13993003.00541-2019. Print 2019 Sep.

  PMID: 31391221 BACKGROUND

• 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.

  PMID: 24394842 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.

  PMID: 34023322 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.

  PMID: 26022948 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.

  PMID: 33515303 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.

  PMID: 35039443 BACKGROUND

MeSH Terms

Conditions

Empyema, Pleural

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Empyema; Suppuration; Pleural Diseases; Respiratory Tract Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Maged Hassan, PhD

CONTACT

+447960357965; maged.mahmoud@alexmed.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 11, 2022
• First Posted: September 21, 2022
• Study Start: September 19, 2022
• Primary Completion: April 1, 2024
• Study Completion: May 1, 2024
• Last Updated: September 27, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be available for a minimum of five years after study conclusion
• Access Criteria: Request for access will be granted when reasonable reasons for request are given

Locations

EG (1)