NCT03905408

Pleurodesis Using Hypertonic Glucose to Treat Post-operative Air Leaks

PLeurodesis Using Hypertonic Glucose Administration to Treat Post-operative Air Leaks Following Lung Resection Surgery (PLUG-I): Phase 1

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The investigators will define the most appropriate safe dose of D50 to heal air leaks in patients that have undergone lung resection surgery

Detailed description

The investigators will define the most appropriate safe dose of D50 to heal air leaks in patients that have undergone lung resection surgery (Phase I study). Air leaks from unhealed lung tissue are one of the most common complications after lung surgery including wedge resection, segmentectomy and lobectomy. Air leaks can lead to a delay in chest tube removal, prolonged pain, increased infections, prolonged hospital stay, and increased costs to the health care system. Different agents have been used to heal air leaks by creating a pleurodesis (adhesions to obliterate the pleural space between the visceral and parietal pleura). The success with these agents has been variable and come with the cost of complications that have restricted their use the post-operative period. There has been recent interest in the use of 50% hypertonic glucose (D50) to create pleurodesis with encouraging reports coming mostly from Asia. The investigators have performed a pilot study using 180 mL of D50 instilled through the chest tube for the management of post lobectomy air leak with very encouraging results. This preliminary study used strict inclusion criteria of only lobectomy patients and excluded all patients with known diabetes or any postoperative hyperglycemia. It is unknown if these patients would have benefitted from D50. Also, the optimal dose of D50 was chosen empirically and never clearly defined by previous work. It has been reported that high doses of D50 have been associated with acute lung injury. It is therefore critical that the optimal safe dose is clarified.

Conditions

• Postoperative Air Leak

Interventions

Type	Name	Description
DRUG	50 mL of 50% Glucose	1st dose
DRUG	100 mL of 50% Glucose	2nd dose
DRUG	150 mL of 50% Glucose	3rd dose
DRUG	200 mL of 50% Glucose	4th dose

Timeline

• Start date: 2019-09-17
• Primary completion: 2021-02-01
• Completion: 2021-02-01
• First posted: 2019-04-05
• Last updated: 2021-05-12

Locations

1 site across 1 country: Canada