Pulmonary Surgical ProceduresPLUGNCT02376218
Post-lobectomy Use of Glucose for Pleurodesis and Air-leak Cessation. A Feasibility Trial.
A study testing Hypertonic 50% dextrose pleurodesis in people with Pulmonary Surgical Procedures, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
It is common practice to leave a chest drainage catheter after lung surgical resections to manage air leaks. The air leakage will usually stop in the initial postoperative days, but in a few patients, it will last for a longer period of time, preventing the removal of the chest tube that can lead to patient… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Surgical Procedures
- What is being tested?
- Hypertonic 50% dextrose pleurodesis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2015to Feb 2016
- Phase
- Interventional
- 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
- Patients aged 18 years or older at the time of surgery
- Having undergone a simple lung lobectomy for malignancy, primary or metastatic
- Procedure performed through thoracotomy, sternotomy or video-assisted thoracic surgery (VATS), and associated or not to mediastinoscopy, staging thoracoscopy, mediastinal lymph nodes sampling or mediastinal lymph nodes dissection
- Normally recovery after a surgery performed between 12 and 24 hours earlier
Who cannot join
- High amount of liquid drainage from chest tube (>500 cc in the last 8 hours)
- Minimal air leak (<20 cc/min in one of the last 4 hours)
- Large air leak (>500 cc/min in one of the last 4 hours)
- History of previous ipsilateral thoracotomy, lung resection, rib fracture, chest trauma, or lung/thoracic infection
- Diabetes or hyperglycemia
- Immunity disorders
Show all 10Show fewer
- Allergy to local anaesthetics
- Hemodynamic instability
- Need for respiratory support
- Inability to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
It is common practice to leave a chest drainage catheter after lung surgical resections to manage air leaks. The air leakage will usually stop in the initial postoperative days, but in a few patients, it will last for a longer period of time, preventing the removal of the chest tube that can lead to patient discomfort, increased likelihood to develop postoperative complications and longer length of hospital stay. Pleurodesis is an effective method to address postoperative air leak which consists in injecting an irritating solution into the chest cavity. This is not performed regularly after lung resections for different reasons including associated pain, costs, and fear of infections. Pleurodesis with hyperosmolar glucose solution have been used for years with good results in some Asian countries because of its simplicity and low cost. Its effectiveness for pleurodesis has been reported in cases of spontaneous pneumothorax and chylothorax, but its efficiency to stop air leaks in the postoperative period remains to be defined.
- Conditions
- Pulmonary Surgical Procedures
- Being tested
- Hypertonic 50% dextrose pleurodesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypertonic 50% dextrose pleurodesisDrug
Intrapleural administration of 180ml of hypertonic dextrose solution.
| Study group | Role | What they receive |
|---|---|---|
| Hypertonic 50% dextrose pleurodesis | Experimental | Not described Receives: Drug: Hypertonic 50% dextrose pleurodesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Air leak cessation
air leak <20 cc/min for 4 hours or more
Measured: 48 hours after time of initial injection of 50% glucose solution
Secondary outcomes (4)
Time to air leak cessation
Measured: 30-day post-operative period
Time to chest tube removal
Measured: 30-day post-operative period
Length of hospitalization
Measured: 30-day post-operative period
Postoperative complications
number of participants with one of the following: o Hyperglycemia o De novo atrial fibrillation o Pneumonia o Empyema o Thromboembolic disorders o Confusion o Need for discharge with chest tube o Recurrent pneumothorax o Need for chest tube reinsertion o Death
Measured: 30-day post-operative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2015 (estimated)
- Study startApr 2015
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Surgical ProceduresStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 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, Eric Frechette, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02376218
- Sponsor's protocol ID
- 105807
- Acronym
- PLUG
- Status last verified
- Feb 2016
- First submitted
- 20 Feb 2015
- Last updated
- 9 Feb 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-lobectomy Use of Glucose for Pleurodesis and Air-leak Cessation. A Feasibility Trial.
- ClinicalTrials.gov ID
- NCT02376218
- Acronym / sponsor ID
- PLUG / 105807
- Conditions
- Pulmonary Surgical Procedures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 3 Mar 2015 (estimated)
- 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.
It is common practice to leave a chest drainage catheter after lung surgical resections to manage air leaks. The air leakage will usually stop in the initial postoperative days, but in a few patients, it will last for a longer period of time, preventing the removal of the chest tube that can lead to patient discomfort, increased likelihood to develop postoperative complications and longer length of hospital stay. Pleurodesis is an effective method to address postoperative air leak which consists in injecting an irritating solution into the chest cavity. This is not performed regularly after lung resections for different reasons including associated pain, costs, and fear of infections. Pleurodesis with hyperosmolar glucose solution have been used for years with good results in some Asian countries because of its simplicity and low cost. Its effectiveness for pleurodesis has been reported in cases of spontaneous pneumothorax and chylothorax, but its efficiency to stop air leaks in the postoperative period remains to be defined.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypertonic 50% dextrose pleurodesis | Experimental | Drug: Hypertonic 50% dextrose pleurodesis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 18 years or older at the time of surgery
- Having undergone a simple lung lobectomy for malignancy, primary or metastatic
- Procedure performed through thoracotomy, sternotomy or video-assisted thoracic surgery (VATS), and associated or not to mediastinoscopy, staging thoracoscopy, mediastinal lymph nodes sampling or mediastinal lymph nodes dissection
- Normally recovery after a surgery performed between 12 and 24 hours earlier
Key exclusion criteria (10 listed)
- High amount of liquid drainage from chest tube (>500 cc in the last 8 hours)
- Minimal air leak (<20 cc/min in one of the last 4 hours)
- Large air leak (>500 cc/min in one of the last 4 hours)
- History of previous ipsilateral thoracotomy, lung resection, rib fracture, chest trauma, or lung/thoracic infection
- Diabetes or hyperglycemia
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 |
|---|---|---|
| Hypertonic 50% dextrose pleurodesisIntrapleural administration of 180ml of hypertonic dextrose solution. | Drug | Hypertonic 50% dextrose pleurodesis |
Primary outcome
Air leak cessation
Time frame: 48 hours after time of initial injection of 50% glucose solution
air leak <20 cc/min for 4 hours or more
4 secondary outcomes
Time to air leak cessation
Time frame: 30-day post-operative period
Time to chest tube removal
Time frame: 30-day post-operative period
Length of hospitalization
Time frame: 30-day post-operative period
Postoperative complications
Time frame: 30-day post-operative period
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 9 Feb 2016.
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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 study testing Hypertonic 50% dextrose pleurodesis in people with Pulmonary Surgical Procedures, 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 10 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 9 Feb 2016. 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.
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?
Air leak cessation (time frame: 48 hours after time of initial injection of 50% glucose solution). 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 9 Feb 2016; AzTrials last refreshed its copy on 8 Nov 2026.