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Trial of Antiseptic Irrigation for Pleural Infection (RINSE)

Primary Purpose

Empyema, Pleural

Status
Recruiting
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Povidone-iodine solution
Normal saline
Sponsored by
Alexandria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Empyema, Pleural

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Alexandria University Faculty of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Antiseptic irrigation arm

Saline irrigation arm

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Time in days to chest tube removal
The time in days from the first irrigation to the chest tube removal
Total length of hospital stay in days
Duration of hospital stay from admission until a patient is declared medically fit for discharge
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
Incidence of medical treatment failure
Number of patients who fail medical treatment (referral to surgery, further pleural procedures or death)
Incidence of adverse events
Number of patients with different types of adverse events

Full Information

First Posted
September 11, 2022
Last Updated
September 26, 2022
Sponsor
Alexandria University
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1. Study Identification

Unique Protocol Identification Number
NCT05546762
Brief Title
Trial of Antiseptic Irrigation for Pleural Infection
Acronym
RINSE
Official Title
IrRigation of the INfected Pleural Space With antiSEptic Solution (RINSE) - a Proof of Concept Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 19, 2022 (Actual)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
May 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Empyema, Pleural

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Antiseptic irrigation arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Saline irrigation arm
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Povidone-iodine solution
Intervention Description
Pleural irrigation with 2% povidone iodine
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
Pleural irrigation with normal saline
Primary Outcome Measure Information:
Title
Percentage change in inflammatory markers before and after irrigation
Description
The percentage by which inflammatory marker (CRP and/or procalcitonin) decrease after completing all irrigations in comparison to the pre-irrigation inflammatory markers level
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
Secondary Outcome Measure Information:
Title
Time in days to chest tube removal
Description
The time in days from the first irrigation to the chest tube removal
Time Frame
At the time of chest tube removal (up to 6 weeks)
Title
Total length of hospital stay in days
Description
Duration of hospital stay from admission until a patient is declared medically fit for discharge
Time Frame
At the point of deciding a patient is medically fit for discharge (assessed up to 6 weeks)
Title
Percentage of radiological clearance between baseline and discharge chest X-rays
Description
Percentage of radiological clearance of pleural abnormalities between baseline and discharge chest X-rays using a computer software
Time Frame
baseline and discharge (up to week 6)
Title
Incidence of medical treatment failure
Description
Number of patients who fail medical treatment (referral to surgery, further pleural procedures or death)
Time Frame
At discharge from the hospital or referral to another department (assessed up to week 6)
Title
Incidence of adverse events
Description
Number of patients with different types of adverse events
Time Frame
Adverse events will be recognised if they appear within 6 hours of a given irrigation procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maged Hassan, PhD
Phone
+447960357965
Email
maged.mahmoud@alexmed.edu.eg
Facility Information:
Facility Name
Alexandria University Faculty of Medicine
City
Alexandria
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maged Hassan, PhD
Email
maged.mahmoud@alexmed.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
Data will be available for a minimum of five years after study conclusion
IPD Sharing Access Criteria
Request for access will be granted when reasonable reasons for request are given
Citations:
PubMed Identifier
31391221
Citation
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.
Results Reference
background
PubMed Identifier
24394842
Citation
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.
Results Reference
background
PubMed Identifier
34023322
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.
Results Reference
background
PubMed Identifier
26022948
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.
Results Reference
background
PubMed Identifier
33515303
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.
Results Reference
background
PubMed Identifier
35039443
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. No abstract available.
Results Reference
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Trial of Antiseptic Irrigation for Pleural Infection

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