Sugar Solution for Air Leaks After Lung Surgery

(PLUG-II Trial)

Overseen By Deb Lewis

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Lawson Health Research Institute

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 5 days

40 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for individuals who have had lung surgery and are experiencing air leaks from the lungs, which is a common issue after such procedures. Specific eligibility criteria were not provided.

Inclusion Criteria

Presence of air leak on postoperative day 1 of at least 100 mL/min, as documented on the digital drainage system

I am an adult scheduled for a specific lung surgery for cancer.

Exclusion Criteria

Not applicable.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Intrapleural administration of Dextrose 50% to resolve air leaks after pulmonary resection

5 days

Daily monitoring post-surgery

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Hypertonic Glucose

Trial Overview The study aims to test if Dextrose 50%, when administered into the pleural space (the area between the lungs and chest wall), can effectively stop air leaks in patients who've undergone lung resection.

Participant Groups

Group I: D50 Experimental Treatment 1 Intervention

A solution of 50% glucose will be injected into the pleural space on the first and possibly the second day after surgery. The injection will be administered through the chest tube, which is already in place.

Group II: Standard of care Active Control 1 Intervention

monitor air leak, if the air leak continues on post-operative day #5, a talc pleurodesis may be given.

Who Is Running the Clinical Trial?

Lawson Health Research Institute

Lead Sponsor

Trials

684

Recruited

432,000+

London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

686

Recruited

427,000+

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

678

Recruited

421,000+

London Health Sciences Centre OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

668

Recruited

424,000+