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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a sugar solution called Dextrose 50% (a form of hypertonic glucose) to determine if it can heal air leaks in the lungs after surgery. Air leaks commonly occur after lung surgery, causing discomfort and slowing recovery. Participants will receive either the sugar solution through their chest tube or standard care, which involves monitoring leaks and possibly another procedure if needed. Ideal participants are adults who have undergone lung surgery for cancer and have a noticeable air leak after the first day. The trial aims to find a quicker and easier way to fix these leaks. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that a strong glucose solution, like the 50% glucose used in this study, has been tested for treating air leaks after lung surgery. In past studies, this type of glucose solution fixed air leaks more effectively than some other treatments. Although it didn't stop air leaks in all patients, it often reduced the amount of air leaking.

Regarding safety, some patients experienced temporary increases in blood sugar levels after receiving the glucose solution. This requires monitoring but is usually manageable. The glucose solution has been used in other studies without major long-term side effects, suggesting it is generally well-tolerated. However, since this is a Phase 2 trial, the treatment is still being tested for safety and effectiveness. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard care for air leaks after lung surgery, which often involves monitoring and potentially using talc pleurodesis, the new treatment uses hypertonic glucose (a solution of 50% glucose) injected directly into the pleural space. Researchers are excited about this approach because it offers a new mechanism of action by potentially sealing air leaks more effectively and quickly. This method utilizes a sugar solution to promote healing, which is different from traditional methods that rely on physical or chemical pleurodesis. Additionally, the delivery through an existing chest tube makes the procedure less invasive and may offer quicker relief for patients.

What evidence suggests that hypertonic glucose might be an effective treatment for air leaks after lung surgery?

This trial will compare the use of a 50% glucose solution, administered to participants in one arm, with standard care for managing air leaks after lung surgery. Research has shown that a strong glucose solution, such as a 50% glucose mix, can help repair air leaks post-surgery. Studies have found that this solution can seal the space around the lungs, preventing air from escaping through unhealed areas. One study discovered that a 40% glucose solution was more effective at fixing air leaks than using a patient's own blood. Another study demonstrated that using a 50% glucose solution to close the space between the lung and chest wall is safe and effective. Overall, strong glucose solutions provide a helpful method for managing and preventing air leaks after surgery. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. academic.oup.com academic.oup.com/ejcts/advance-article-pdf/doi/10.1093/ejcts/ezaf382/65175524/ezaf382.pdf

ACCEPTED MANUSCRIPT - Oxford Academic Conclusions Intrapleural 40% glucose solution achieved a higher resolution rate of postoperative air leak compared to autologous blood patch ...

2. jchestsurg.org jchestsurg.org/journal/view.html?uid=6458&vmd=Full

Early Pleurodesis for Postoperative Air Leak with ... This study evaluated the feasibility of an early intervention to stop postoperative air leaks with either autologous blood or a 50% glucose solution.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4819551/

Novel approach to pleurodesis with 50 % glucose for air ... Pleurodesis with 50 % glucose is an easy, safe, and effective treatment modality. It is therefore considered to be a useful alternative method for pleurodesis.

4. ctv.veeva.com ctv.veeva.com/study/pleurodesis-using-hypertonic-glucose-to-treat-post-operative-air-leaks

Pleurodesis Using Hypertonic Glucose to Treat Post-operative ... Air leaks from unhealed lung tissue are one of the most common complications after lung surgery including wedge resection, segmentectomy and ...

5. mdpi.com mdpi.com/1648-9144/60/5/802

Advancements in the Management of Postoperative Air ... Its effectiveness in sealing the pleural space and preventing the recurrence of air leaks makes it a valuable option in the comprehensive management of PAL [32, ...

6. trial.medpath.com trial.medpath.com/clinical-trial/d12899cc3882e287/nct03905408-pleurodesis-hypertonic-glucose-air-leaks

Pleurodesis Using Hypertonic Glucose to Treat Post-operative ... The investigators will define the most appropriate safe dose of D50 to heal air leaks in patients that have undergone lung resection surgery.

7. withpower.com withpower.com/trial/phase-2-air-leak-from-lung-2-2024-f9ba6

Sugar Solution for Air Leaks After Lung Surgery The purpose of this study is to investigate the efficacy of intrapleural administration of Dextrose 50% to resolve air leaks after pulmonary resection. Show ...