Skip to main content
OpenTrials
Completed

NCT Number: NCT04761133

Antiseptic Irrigation for Pleural Infection

The antiseptic povidone-iodine can safely be instilled into the pleural for the purpose of pleurodesis. Pleural irrigation with antiseptics is used in adults with open drainage for chronic empyema and has been described in the acute management of paediatric pleural infection.

This study will investigate the safety and usefulness of povidone-iodine pleural irrigation in 15 eligible patients recruited to the Pleural Infection Cohort Study (PICS) with acute pleural infection. A matched control group will be used and will be composed of 15 patients previously recruited to PICS without receiving povidone-iodine pleural irrigation.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Alexandria University Faculty of Medicine

Alexandria, Egypt

About this study

Pleural infection is a condition that requires hospitalization for management and is associated with significant in-hospital morbidity and mortality. Predictors of poor outcome include advancing age, poor nutrition, hospital-acquired infection and impaired renal function. Medical management is centred on appropriate antibiotic treatment and fluid drainage usually by the means of an intercostal tube. Up to 30% of patients fail medical treatment and referred for surgery. A recent systematic review of adults patient with pleural infection has shown that the demographics of patients with pleural infection are different in patients from high-income vs lower income countries; the latter being of younger age and lower comorbidity burden. However, the results of the review did not show significant differences in patient outcomes. The same systematic review pointed to the need for more data from patients residing in lower income countries given that the majority of data is contributed by studies from higher income countries.

This platform study aims to prospectively investigate the incidence of pleural infection in a large tertiary centre gathering demographic and clinical data about patients recruited. In addition, the study will examine the different treatment offered and how this related to in-hospital outcomes (length of hospital stay, rate of referral to surgery and mortality).

The study will be designed as a modified trial within cohort (TwiC) study. PICS will primarily aim to recruit patients prospectively to gather clinical and demographic data on patients admitted with pleural infection in addition to clinical data on tests performed and treatments received as part of the standard care. The in-patient outcomes will be recorded at the time of discharge data or death, whichever is earlier. Within the TWIC design, PICS will be a platform for recruiting patients to interventional trials for eligible patients within the cohort. As a planned sub-study, pleural antiseptics will be trialed within a subset of patients enrolled.

The antiseptic povidone-iodine can safely be instilled into the pleural for the purpose of pleurodesis. Pleural irrigation with antiseptics is used in adults with open drainage for chronic empyema and has been described in the acute management of paediatric pleural infection.

This sub-study will investigate the safety and usefulness of povidone-iodine pleural irrigation in 15 eligible adult patients recruited to PICS with acute pleural infection. A matched control group will be used and will be composed of 15 patients previously recruited to PICS without receiving povidone-iodine pleural irrigation.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All adult patients admitted to hospital with pleural infection and had a chest tube inserted for treatment of the infection. Pleural infection will be defined by the presence of one of the following: a) the presence of pus in the pleural space; b) positive pleural fluid gram stain or culture; or c) pleural fluid pH < 7.2 or pleural fluid glucose < 40 mg/dL in the setting of acute respiratory infection.
  • Pleural collection is unilocular on pre-drainage imaging. Presence of septations on ultrasound examination is allowed.

Exclusion criteria

  • Known or suspected thyroid disease
  • Allergy to iodine
  • Persistent large collection on follow up imaging 24-48 of post tube insertion that requires another drainage procedure

Treatment and study plan

Povidone-Iodine pleural irrigation

Drug

Irrigation of the infected pleural cavity with an antiseptic solution to reduce microbial load

Other names: Betadine

Primary outcomes

  1. Incidence of adverse events

    Time frame: Within 24 hours after the second application of the study medication

    Number of subjects with any adverse event (new chest pain, fever, dyspnoea or oxygen desaturation)

  2. Time to chest tube removal

    Time frame: Up to 8 weeks

    Number of days from tube insertion to tube removal

Secondary outcomes

  1. Time to defervescence

    Time frame: Up to 8 weeks

    Numbers of days until resolution of fever

  2. Length of hospital stay

    Time frame: Up to 8 weeks

    Number of days from admission/diagnosis until discharge from hospital

  3. Incidence of need for additional aspiration/tubes

    Time frame: Up to 8 weeks

    Number of patients requiring additional drainage procedures during hospital admission

  4. Incidence of medical treatment of failure

    Time frame: Up to 8 weeks

    Number of patients requiring surgical intervention

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

Antiseptic Pleural Irrigation for Patients With Pleural Infection

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 18, 2021
Registry last updated
Aug 31, 2022

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.

Published trials that share one or more normalized conditions with this study.