Pleurodesis Using Hypertonic Glucose (PLUG-II)

March 1, 2024 updated by: Mehdi Qiabi, Lawson Health Research Institute

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 5W9
        • London Health Sciences Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: D50
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.
Drug: Dextrose 50
a solution of 50% glucose (D50) will be injected into your pleural space
Other Names:
  • D50
Active Comparator: Standard of care
monitor air leak, if the air leak continues on post-operative day #5, a talc pleurodesis may be given.
Other: Standard of Care - No Dextrose 50
Standard of Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prolonged Air Leak
Time Frame: 5 days postoperatively
Prolonged Air Leak
5 days postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of Chest Tubes
Time Frame: immediately after the surgery
Duration of Chest Tubes
immediately after the surgery
Home with Chest Tube
Time Frame: immediately after the surgery
Home with Chest Tube (y/n)
immediately after the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lawson Health Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 30, 2024

Primary Completion (Estimated)

April 30, 2025

Study Completion (Estimated)

April 30, 2025

Study Registration Dates

First Submitted

February 25, 2024

First Submitted That Met QC Criteria

March 1, 2024

First Posted (Actual)

March 5, 2024

Study Record Updates

Last Update Posted (Actual)

March 5, 2024

Last Update Submitted That Met QC Criteria

March 1, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PLUG-II

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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