Pleurodesis Using Hypertonic Glucose (PLUG-II)

Lawson Health Research Institute

Status and phase: Not yet enrolling; Phase 2

Conditions: Air Leak From Lung

Treatments: Other: Standard of Care - No Dextrose 50; Drug: Dextrose 50

Study type: Interventional

Funder types: Other

Identifiers

NCT06293885

PLUG-II

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

D50

Experimental group

Description:

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.

Treatment:

Drug: Dextrose 50

Standard of care

Active Comparator group

Description:

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

Treatment:

Other: Standard of Care - No Dextrose 50