Ignite Creation Date:
2025-12-25 @ 4:57 AM
Ignite Modification Date:
2025-12-26 @ 3:57 AM
Study NCT ID:
NCT02376218
Status:
COMPLETED
Last Update Posted:
2016-02-09
First Post:
2015-02-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Post-lobectomy Use of Glucose for Pleurodesis and Air-leak Cessation. A Feasibility Trial.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-08', 'studyFirstSubmitDate': '2015-02-20', 'studyFirstSubmitQcDate': '2015-02-25', 'lastUpdatePostDateStruct': {'date': '2016-02-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Air leak cessation', 'timeFrame': '48 hours after time of initial injection of 50% glucose solution', 'description': 'air leak \\<20 cc/min for 4 hours or more'}], 'secondaryOutcomes': [{'measure': 'Time to air leak cessation', 'timeFrame': '30-day post-operative period'}, {'measure': 'Time to chest tube removal', 'timeFrame': '30-day post-operative period'}, {'measure': 'Length of hospitalization', 'timeFrame': '30-day post-operative period'}, {'measure': 'Postoperative complications', 'timeFrame': '30-day post-operative period', 'description': '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'}]}, 'conditionsModule': {'conditions': ['Pulmonary Surgical Procedures']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 18 years or older at the time of surgery\n* Having undergone a simple lung lobectomy for malignancy, primary or metastatic\n* 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\n* Normally recovery after a surgery performed between 12 and 24 hours earlier\n\nExclusion Criteria:\n\n* High amount of liquid drainage from chest tube (\\>500 cc in the last 8 hours)\n* Minimal air leak (\\<20 cc/min in one of the last 4 hours)\n* Large air leak (\\>500 cc/min in one of the last 4 hours)\n* History of previous ipsilateral thoracotomy, lung resection, rib fracture, chest trauma, or lung/thoracic infection\n* Diabetes or hyperglycemia\n* Immunity disorders\n* Allergy to local anaesthetics\n* Hemodynamic instability\n* Need for respiratory support\n* Inability to give informed consent'}, 'identificationModule': {'nctId': 'NCT02376218', 'acronym': 'PLUG', 'briefTitle': 'Post-lobectomy Use of Glucose for Pleurodesis and Air-leak Cessation. A Feasibility Trial.', 'organization': {'class': 'OTHER', 'fullName': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's"}, 'officialTitle': 'Post-lobectomy Use of Glucose for Pleurodesis and Air-leak Cessation. A Feasibility Trial.', 'orgStudyIdInfo': {'id': '105807'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hypertonic 50% dextrose pleurodesis', 'interventionNames': ['Drug: Hypertonic 50% dextrose pleurodesis']}], 'interventions': [{'name': 'Hypertonic 50% dextrose pleurodesis', 'type': 'DRUG', 'description': 'Intrapleural administration of 180ml of hypertonic dextrose solution.', 'armGroupLabels': ['Hypertonic 50% dextrose pleurodesis']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N6A 5W9', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'London Health Sciences Centre', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Eric Frechette', 'investigatorAffiliation': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's"}}}}