Postoperative Air LeakPhase 1PLUG-INCT03905408
Pleurodesis Using Hypertonic Glucose to Treat Post-operative Air Leaks
A Phase 1 study testing 50 mL of 50% Glucose, 100 mL of 50% Glucose and 150 mL of 50% Glucose in people with Postoperative Air Leak, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
The investigators will define the most appropriate safe dose of D50 to heal air leaks in patients that have undergone lung resection surgery Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Air Leak
- What is being tested?
- 50 mL of 50% Glucose, 100 mL of 50% Glucose and 150 mL of 50% Glucose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- 17 Sep 2019to 1 Feb 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PLeurodesis Using Hypertonic Glucose Administration to Treat Post-operative Air Leaks Following Lung Resection Surgery (PLUG-I): Phase 1
The investigators will define the most appropriate safe dose of D50 to heal air leaks in patients that have undergone lung resection surgery
Read the 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
- Being tested
- 50 mL of 50% Glucose, 100 mL of 50% Glucose, 150 mL of 50% Glucose, 200 mL of 50% Glucose
- Keywords
- glucose, lung surgery, air leak, postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
50 mL of 50% GlucoseDrug
Also called Dextrose
1st dose
100 mL of 50% GlucoseDrug
Also called Dextrose
2nd dose
150 mL of 50% GlucoseDrug
Also called Dextrose
3rd dose
200 mL of 50% GlucoseDrug
Also called Dextrose
4th dose
| Study group | Role | What they receive |
|---|---|---|
| 50 mL Dextrose | Experimental | 50 mL of 50% dextrose Receives: Drug: 50 mL of 50% Glucose |
| 100 mL Dextrose | Experimental | 100 mL of 50% dextrose Receives: Drug: 100 mL of 50% Glucose |
| 150 mL Dextrose | Experimental | 150 mL of 50% dextrose Receives: Drug: 150 mL of 50% Glucose |
| 200 mL Dextrose | Experimental | 200 mL of 50% dextrose Receives: Drug: 200 mL of 50% Glucose |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2019
- Study start17 Sep 2019
- Primary completion1 Feb 2021
- Study completion1 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Air LeakStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- 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)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Malthaner, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03905408
- Sponsor's protocol ID
- PLUG-I
- Acronym
- PLUG-I
- Status last verified
- May 2021
- First submitted
- 26 Mar 2019
- Last updated
- 12 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PLeurodesis Using Hypertonic Glucose Administration to Treat Post-operative Air Leaks Following Lung Resection Surgery (PLUG-I): Phase 1
- ClinicalTrials.gov ID
- NCT03905408
- Acronym / sponsor ID
- PLUG-I / PLUG-I
- Conditions
- Postoperative Air Leak
- Keywords
- glucose, lung surgery, air leak, postoperative
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 17 Sep 2019 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 5 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- 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%
| Arm | Type | Receives |
|---|---|---|
| 50 mL Dextrose | Experimental | Drug: 50 mL of 50% Glucose50 mL of 50% dextrose |
| 100 mL Dextrose | Experimental | Drug: 100 mL of 50% Glucose100 mL of 50% dextrose |
| 150 mL Dextrose | Experimental | Drug: 150 mL of 50% Glucose150 mL of 50% dextrose |
| 200 mL Dextrose | Experimental | Drug: 200 mL of 50% Glucose200 mL of 50% dextrose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 50 mL of 50% GlucoseAlso: Dextrose1st dose | Drug | 50 mL Dextrose |
| 100 mL of 50% GlucoseAlso: Dextrose2nd dose | Drug | 100 mL Dextrose |
| 150 mL of 50% GlucoseAlso: Dextrose3rd dose | Drug | 150 mL Dextrose |
| 200 mL of 50% GlucoseAlso: Dextrose4th dose | Drug | 200 mL Dextrose |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 50 mL of 50% Glucose, 100 mL of 50% Glucose and 150 mL of 50% Glucose in people with Postoperative Air Leak, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of treatment related adverse events (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2021.