Pleurodesis Using Hypertonic Glucose

Air Leak From Lung Clinical Trial

— PLUG-II  

Official title:

PLeurodesis Using Hypertonic Glucose Administration to Treat Post-operative Air Leaks Following Lung Resection Surgery (PLUG): Phase II Randomized Feasibility Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06293885
• Other study ID #: PLUG-II
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: March 30, 2024
• Est. completion date: April 30, 2025

Study information

• Verified date: March 2024
• Source: Lawson Health Research Institute
• Contact: Deb Lewis
• Phone: 519-685-8500
• Email: deb.lewis[@]lhsc.on.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Air leaks from unhealed lung tissue following lung resection for benign or malignant lesions are one of the most common complications following thoracic surgery, occurring after 10% of major lung resections. The purpose of this study is to investigate the efficacy of intrapleural administration of Dextrose 50% to resolve air leaks after pulmonary resection.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients undergoing scheduled pulmonary lobar or sublobar resection for cancer
• Presence of air leak on postoperative day 1 of at least 100 mL/min, as documented on the digital drainage system

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Air Leak From Lung

Intervention

Drug:
• Dextrose 50
a solution of 50% glucose (D50) will be injected into your pleural space

Other:
• Standard of Care - No Dextrose 50
Standard of Care

Locations

Country	Name	City	State
Canada	London Health Sciences Centre	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prolonged Air Leak	Prolonged Air Leak	5 days postoperatively
Secondary	Duration of Chest Tubes	Duration of Chest Tubes	immediately after the surgery
Secondary	Home with Chest Tube	Home with Chest Tube (y/n)	immediately after the surgery