Pleurodesis Using Hypertonic Glucose to Treat Post-operative Air Leaks

NCT03905408 | Completed Phase 1

• 1 other identifier: PLUG-I
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Conditions

Postoperative Air Leak

Keywords

glucose; lung surgery; air leak; postoperative

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

50 mL Dextrose

EXPERIMENTAL

50 mL of 50% dextrose

Drug: 50 mL of 50% Glucose

100 mL Dextrose

EXPERIMENTAL

100 mL of 50% dextrose

Drug: 100 mL of 50% Glucose

150 mL Dextrose

EXPERIMENTAL

150 mL of 50% dextrose

Drug: 150 mL of 50% Glucose

200 mL Dextrose

EXPERIMENTAL

200 mL of 50% dextrose

Drug: 200 mL of 50% Glucose

Interventions

50 mL of 50% Glucose DRUG

1st dose

Also known as: Dextrose

50 mL Dextrose

100 mL of 50% Glucose DRUG

2nd dose

Also known as: Dextrose

100 mL Dextrose

150 mL of 50% Glucose DRUG

3rd dose

Also known as: Dextrose

150 mL Dextrose

200 mL of 50% Glucose DRUG

4th dose

Also known as: Dextrose

200 mL Dextrose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old or older
• Lung resection is a wedge, segmentectomy, lobectomy or bilobectomy
• Procedure performed by video-assisted thoracic surgery (VATS) or by Thoracotomy
• Presence of an air leak on the digital draining system on postoperative day 2

You may not qualify if:

• Large air leak arbitrarily defined as more than 1000 mL/min
• Allergy to local anesthetics
• Hemodynamic instability
• Untreated coronary artery disease
• Need for respiratory support
• Any other early post-operative complication
• Immunity disorder
• Large pleural fluid output empirically defined as more than 500 mL in the last 12 hours
• Inability to give consent
• Fasting glucose ≥ 14 mmol/L the morning of the intervention (arbitrarily chosen cut-off in which patients' diabetes is considered very poorly controlled)
• Endocrinology service not available to co-manage patients with either diabetes, or a fasting blood glucose ≥ 7 mmol/L, or HbA1c \> 6.5%
• 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)

Sponsors & Collaborators

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

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location

MeSH Terms

Interventions

Glucose

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Chair/Chief Thoracic Surgery

Model Details: Escalating dose: Arm 1: 50 mL dextrose 50% Arm 2: 100 mL dextrose 50% Arm 3: 150 mL dextrose 50% Arm 4:, 200 mL dextrose 50%

Study Record Dates

• First Submitted: March 26, 2019
• First Posted: April 5, 2019
• Study Start: September 17, 2019
• Primary Completion: February 1, 2021
• Study Completion: February 1, 2021
• Last Updated: May 12, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)