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Completed

NCT Number: NCT03905408

Pleurodesis Using Hypertonic Glucose to Treat Post-operative Air Leaks

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 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

Exclusion criteria

  • 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)

Treatment and study plan

50 mL of 50% Glucose

Drug

1st dose

Other names: Dextrose

100 mL of 50% Glucose

Drug

2nd dose

Other names: Dextrose

150 mL of 50% Glucose

Drug

3rd dose

Other names: Dextrose

200 mL of 50% Glucose

Drug

4th dose

Other names: Dextrose

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Acronym: PLUG-I

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Apr 5, 2019
Registry last updated
May 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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