Pleurodesis Using Hypertonic Glucose to Treat Post-operative Air Leaks

Postoperative Air Leak Clinical Trial

— PLUG-I  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03905408
• Other study ID #: PLUG-I
• Status: Completed
• Phase: Phase 1
• Start date: September 17, 2019
• Est. completion date: February 1, 2021

Study information

• Verified date: May 2021
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: February 1, 2021
• Est. primary completion date: February 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 18 years old or older

2. Lung resection is a wedge, segmentectomy, lobectomy or bilobectomy

3. Procedure performed by video-assisted thoracic surgery (VATS) or by Thoracotomy

4. Presence of an air leak on the digital draining system on postoperative day 2

Exclusion Criteria:

1. Large air leak arbitrarily defined as more than 1000 mL/min

2. Allergy to local anesthetics

3. Hemodynamic instability

4. Untreated coronary artery disease

5. Need for respiratory support

6. Any other early post-operative complication

7. Immunity disorder

8. Large pleural fluid output empirically defined as more than 500 mL in the last 12 hours

9. Inability to give consent

10. Fasting glucose = 14 mmol/L the morning of the intervention (arbitrarily chosen cut-off in which patients' diabetes is considered very poorly controlled)

11. Endocrinology service not available to co-manage patients with either diabetes, or a fasting blood glucose = 7 mmol/L, or HbA1c > 6.5%

12. Postoperative evidence of an active thoracic (lung or pleura) infection with systemic inflammatory response syndrome (2 or more of temperature > 38, heart rate > 90, respiratory rate > 20, white blood cell count > 12)

Related Conditions & MeSH terms

• Postoperative Air Leak

Intervention

Drug:
• 50 mL of 50% Glucose
1st dose
• 100 mL of 50% Glucose
2nd dose
• 150 mL of 50% Glucose
3rd dose
• 200 mL of 50% Glucose
4th dose

Locations

Country	Name	City	State
Canada	London Health Sciences Centre	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of treatment related adverse events	occurrence of treatment related adverse events (Grade 3 and more as assessed to the CTCAE v4.0) at any given dose of D50	1 year