PLeurodesis Using hypertonic Glucose administration to treat post-operative air leaks following lung resection surgery (PLUG): Phase I trial
Abstract
Introduction: Pulmonary air leaks from unhealed lung tissue are one of the most common complications after lung surgery. This adverse event leads to a delay in chest tube removal, prolonged pain, increased infections, prolonged hospital stay, and increased costs to the health care system. Objective: To define the most appropriate safe dose of dextrose 50% (D50) to seal air leaks in patients that have undergone lung resection surgery. Primary outcome was the occurrence of any adverse event. Methods: Prospective, single-arm, single-center, rule-based escalation traditional 3+3 design phase I trial where patients with an active air leak on postoperative day #2 received intrapleural D50 at various dosage. Results: 12 patients were recruited. Increments of 50 mL, 100 mL, 150 mL and 200 mL were tested. There was no severe adverse event. Air leak volume significantly decreased in the 24 hours following D50 administration compared to before (221 vs 31 L, p=0.013). Chest tube output remained similar (282 vs 365 mL, p=0.198). Transient non-significant increase of glycemia was noted 1 hours after D50 (7.4 vs 10.0 mmol/L, p=0.156). 33% (4/12) were discharged home with a one-way valve. Pain level was not impacted by D50. Conclusion: Hypertonic intrapleural glucose to treat air leaks after lung resection appears safe. The optimum dose is 150 mL. Its efficacy is promising and needs to be further studied prospectively.