Pleurodesis Using Hypertonic Glucose to Treat Post-operative Air Leaks (PLUG-I)

Lawson Health Research Institute

Status and phase: Completed; Phase 1

Conditions: Postoperative Air Leak

Treatments: Drug: 50 mL of 50% Glucose; Drug: 150 mL of 50% Glucose; Drug: 100 mL of 50% Glucose; Drug: 200 mL of 50% Glucose

Study type: Interventional

Funder types: Other

Identifiers

NCT03905408

PLUG-I

Details and patient eligibility

About

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

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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12 participants in 4 patient groups

50 mL Dextrose

Experimental group

Description:

50 mL of 50% dextrose

Treatment:

Drug: 50 mL of 50% Glucose

100 mL Dextrose

Experimental group

Description:

100 mL of 50% dextrose

Treatment:

Drug: 100 mL of 50% Glucose

150 mL Dextrose

Experimental group

Description:

150 mL of 50% dextrose

Treatment:

Drug: 150 mL of 50% Glucose

200 mL Dextrose

Experimental group

Description:

200 mL of 50% dextrose

Treatment:

Drug: 200 mL of 50% Glucose