Pleurodesis Using Hypertonic Glucose | NCT06293885

Studies
Pleurodesis Using Hypertonic Glucose

NCT06293885

Sponsor

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

Status

Unknown status

Last Update Posted

Mar 5, 2024Actual

Enrollment

40Estimated

Phase

Phase 2

Conditions

Air Leak From Lung

Interventions

Dextrose 50
Standard of Care - No Dextrose 50

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 30, 2024Estimated

Primary Completion Date

Apr 30, 2025Estimated

Completion Date

Apr 30, 2025Estimated

First Submitted Date

Feb 25, 2024

First Submission Date that Met QC Criteria

Mar 1, 2024

First Posted Date

Mar 5, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 1, 2024

Last Update Posted Date

Mar 5, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mehdi Qiabi, Thoracic Surgeon, Assistant Professor, Western university, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sPrincipal Investigator

Lead Sponsor

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

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Air leaks from unhealed lung tissue following lung resection for benign or malignant lesions are one of the most common complications following thoracic surgery, occurring after 10% of major lung resections. The purpose of this study is to investigate the efficacy of intrapleural administration of Dextrose 50% to resolve air leaks after pulmonary resection.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
D50	Experimental	A solution of 50% glucose will be injected into the pleural space on the first and possibly the second day after surgery. The injection will be administered through the chest tube, which is already in place.	Drug: Dextrose 50
Standard of care	Active Comparator	monitor air leak, if the air leak continues on post-operative day #5, a talc pleurodesis may be given.	Other: Standard of Care - No Dextrose 50

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dextrose 50	Drug	a solution of 50% glucose (D50) will be injected into your pleural space	D50

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prolonged Air Leak	Prolonged Air Leak	5 days postoperatively

Secondary Outcomes

Measure	Description	Time Frame
Duration of Chest Tubes	Duration of Chest Tubes	immediately after the surgery
Home with Chest Tube	Home with Chest Tube (y/n)	immediately after the surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult patients undergoing scheduled pulmonary lobar or sublobar resection for cancer
Presence of air leak on postoperative day 1 of at least 100 mL/min, as documented on the digital drainage system

Exclusion Criteria:

- None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Deb Lewis	Contact	519-685-8500	75685	deb.lewis@lhsc.on.ca

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
London Health Sciences Centre		London	Ontario	N6A 5W9	Canada