Air Leak From LungPhase 2PLUG-IINCT06293885
Pleurodesis Using Hypertonic Glucose
A Phase 2 study testing Dextrose 50 in people with Air Leak From Lung, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Air Leak From Lung
- What is being tested?
- Dextrose 50
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 30 Mar 2024to 30 Apr 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Air Leak From Lung
- Being tested
- Dextrose 50, Standard of Care - No Dextrose 50
- Keywords
- air leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dextrose 50Drug
Also called D50
a solution of 50% glucose (D50) will be injected into your pleural space
Standard of Care - No Dextrose 50Other
Standard of Care
| Study group | Role | What they receive |
|---|---|---|
| D50 | Experimental | 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. Receives: Drug: Dextrose 50 |
| Standard of care | Active comparator | monitor air leak, if the air leak continues on post-operative day #5, a talc pleurodesis may be given. Receives: Other: Standard of Care - No Dextrose 50 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prolonged Air Leak
Prolonged Air Leak
Measured: 5 days postoperatively
Secondary outcomes (2)
Duration of Chest Tubes
Duration of Chest Tubes
Measured: immediately after the surgery
Home with Chest Tube
Home with Chest Tube (y/n)
Measured: immediately after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start30 Mar 2024 (estimated)
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Air Leak From LungStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehdi Qiabi, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06293885
- Sponsor's protocol ID
- PLUG-II
- Acronym
- PLUG-II
- Status last verified
- Mar 2024
- First submitted
- 25 Feb 2024
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PLeurodesis Using Hypertonic Glucose Administration to Treat Post-operative Air Leaks Following Lung Resection Surgery (PLUG): Phase II Randomized Feasibility Trial
- ClinicalTrials.gov ID
- NCT06293885
- Acronym / sponsor ID
- PLUG-II / PLUG-II
- Conditions
- Air Leak From Lung
- Keywords
- air leak
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 30 Mar 2024 (estimated)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 5 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| D50 | Experimental | Drug: Dextrose 50A 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. |
| Standard of care | Active comparator | Other: Standard of Care - No Dextrose 50monitor air leak, if the air leak continues on post-operative day #5, a talc pleurodesis may be given. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dextrose 50Also: D50a solution of 50% glucose (D50) will be injected into your pleural space | Drug | D50 |
| Standard of Care - No Dextrose 50Standard of Care | Other | Standard of care |
Primary outcome
Prolonged Air Leak
Time frame: 5 days postoperatively
Prolonged Air Leak
2 secondary outcomes
Duration of Chest Tubes
Time frame: immediately after the surgery
Home with Chest Tube
Time frame: immediately after the surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dextrose 50 in people with Air Leak From Lung, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Deb Lewis (519-685-8500 ext. 75685, deb.lewis@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prolonged Air Leak (time frame: 5 days postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2024.