Pleurodesis Using Hypertonic Glucose to Treat Post-operative Air Leaks

NCT ID: NCT03905408

Last Updated: 2021-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-17
• Study Completion Date: 2021-02-01

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

50 mL Dextrose

50 mL of 50% dextrose

Group Type: EXPERIMENTAL

50 mL of 50% Glucose

Intervention Type: DRUG

1st dose

100 mL Dextrose

100 mL of 50% dextrose

Group Type: EXPERIMENTAL

100 mL of 50% Glucose

Intervention Type: DRUG

2nd dose

150 mL Dextrose

150 mL of 50% dextrose

Group Type: EXPERIMENTAL

150 mL of 50% Glucose

Intervention Type: DRUG

3rd dose

200 mL Dextrose

200 mL of 50% dextrose

Group Type: EXPERIMENTAL

200 mL of 50% Glucose

Intervention Type: DRUG

4th dose

Interventions

50 mL of 50% Glucose

1st dose

Intervention Type: DRUG

100 mL of 50% Glucose

2nd dose

Intervention Type: DRUG

150 mL of 50% Glucose

3rd dose

Intervention Type: DRUG

200 mL of 50% Glucose

4th dose

Intervention Type: DRUG

Other Intervention Names

Dextrose; Dextrose; Dextrose; Dextrose

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role: lead

Responsible Party

Richard Malthaner

MD, Chair/Chief Thoracic Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

London Health Sciences Centre

London, Ontario, Canada

Countries

Canada

Other Identifiers

PLUG-I

Identifier Type: -

Identifier Source: org_study_id