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

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ClinicalTrials.gov Identifier: NCT03905408
Recruitment Status : Completed
First Posted : April 5, 2019
Last Update Posted : May 12, 2021
Sponsor:
Information provided by (Responsible Party):
Richard Malthaner, Lawson Health Research Institute

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

Condition or disease Intervention/treatment Phase
Postoperative Air Leak Drug: 50 mL of 50% Glucose Drug: 100 mL of 50% Glucose Drug: 150 mL of 50% Glucose Drug: 200 mL of 50% Glucose Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:

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%

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PLeurodesis Using Hypertonic Glucose Administration to Treat Post-operative Air Leaks Following Lung Resection Surgery (PLUG-I): Phase 1
Actual Study Start Date : September 17, 2019
Actual Primary Completion Date : February 1, 2021
Actual Study Completion Date : February 1, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

Arm Intervention/treatment
Experimental: 50 mL Dextrose
50 mL of 50% dextrose
Drug: 50 mL of 50% Glucose
1st dose
Other Name: Dextrose

Experimental: 100 mL Dextrose
100 mL of 50% dextrose
Drug: 100 mL of 50% Glucose
2nd dose
Other Name: Dextrose

Experimental: 150 mL Dextrose
150 mL of 50% dextrose
Drug: 150 mL of 50% Glucose
3rd dose
Other Name: Dextrose

Experimental: 200 mL Dextrose
200 mL of 50% dextrose
Drug: 200 mL of 50% Glucose
4th dose
Other Name: Dextrose




Primary Outcome Measures :
  1. Occurrence of treatment related adverse events [ Time Frame: 1 year ]
    occurrence of treatment related adverse events (Grade 3 and more as assessed to the CTCAE v4.0) at any given dose of D50



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03905408


Locations
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Canada, Ontario
London Health Sciences Centre
London, Ontario, Canada, N6A 5W9
Sponsors and Collaborators
Lawson Health Research Institute
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Responsible Party: Richard Malthaner, MD, Chair/Chief Thoracic Surgery, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT03905408    
Other Study ID Numbers: PLUG-I
First Posted: April 5, 2019    Key Record Dates
Last Update Posted: May 12, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Richard Malthaner, Lawson Health Research Institute:
glucose
lung surgery
air leak
postoperative