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NCT Number: NCT05546762

Trial of Antiseptic Irrigation for Pleural Infection

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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Key information

Conditions

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

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Alexandria University Faculty of Medicine

Alexandria, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Povidone-iodine solution

Drug

Pleural irrigation with 2% povidone iodine

normal saline

Drug

Pleural irrigation with normal saline

Primary outcomes

  1. Percentage change in inflammatory markers before and after irrigation

    Time frame: 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 outcomes

  1. Time in days to chest tube removal

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

    The time in days from the first irrigation to the chest tube removal

  2. Total length of hospital stay in days

    Time frame: 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

  3. Percentage of radiological clearance between baseline and discharge chest X-rays

    Time frame: 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

  4. Incidence of medical treatment failure

    Time frame: 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)

  5. Incidence of adverse events

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

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

Acronym: RINSE

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Sep 21, 2022
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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