Back to resultsColchicine in Postoperative Fontan Patients (CPFP)
Primary Purpose
Single-ventricle, Heart Diseases
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Colchicine
Sponsored by
About this trial
This is an interventional treatment trial for Single-ventricle focused on measuring Fontan, Colchicine, heart surgery
Eligibility Criteria
Inclusion Criteria:
- Ages 20 months to 5 years and 364 days are eligible
- Diagnosed with single ventricle heart disease requiring Fontan palliation
- Undergoing Fontan palliation at the University of Michigan Congenital Heart Center
- Ability to take oral or enteral medication
Exclusion Criteria:
- Treatment with another investigational drug within 3 months
- Pre-existing myelosuppression or decreased bone marrow activity.
- Current or recent treatment with certain drugs
- Renal or hepatic impairment deemed by the study team
- Conditions and/or post-operative complications that would increase risk to the patient such as mechanical support (ECMO) or issues in the intensive care unit (ICU)
Sites / Locations
- University of Michigan
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Colchicine
Arm Description
Colchicine will be given at 0.6 mg once daily for the duration of chest tube output plus 24 hours after chest tube removal with a maximum of 4 weeks duration.
Outcomes
Primary Outcome Measures
Change in Cytokine Total Mass in Pleural Fluid From Patients Treated With Colchicine
Cytokine total mass measured by the Bio-rad Bio-Plex ProHuman Cytokine 17-plex Assay.
Difference in Change of Cytokine Concentrations in Pleural Fluid Patients Treated With Colchicine Compared to Historical Controls
Difference is shown via two columns of separate data, but given that enrollment didn't meet target before termination statistical analysis was not done for this measure
Secondary Outcome Measures
Cytokine Total Mass as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine
Particularly Cytokine total mass of TNF-α, MIP-1β, IL-8, and IL-10, determined by the Bio-rad Bio-Plex ProHuman Cytokine 17-plex Assay
Data was only collected while patients had chest tubes in place (up to 7 days only)
Difference in Cytokine Total Mass, as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine in Comparison to a Cohort of Postoperative Fontan Patients
Cytokine total mass measured by Bio-rad Bio-Plex ProHuman Cytokine 17-plex Assay
Data was only collected from Colchicine patients while they had chest tubes in place (up to 7 days). For historical controls data was collected up through Day 10
Duration of Pleural Drainage as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine
Duration is measured in days, from date of Fontan surgery to chest tube drainage discontinuation.
Difference of Duration of Pleural Drainage of Two Groups, in Empiric Treatment With Colchicine Compared to a Cohort of Fontan Patients Not Treated With Colchicine
Duration is measured in days, from date of Fontan surgery to chest tube drainage discontinuation
Hospital Length of Stay as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine
Measured in days, from date of Fontan surgery to chest tube drainage discontinuation
Difference in Hospital Length of Stay
Measured in days compared to historical controls
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03575572
Brief Title
Colchicine in Postoperative Fontan Patients
Acronym
CPFP
Official Title
Colchicine in Postoperative Fontan Patients (CPFP)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Terminated
Why Stopped
Staffing changes impacted by COVID-19 pandemic resulting in inadequate personnel to facilitate study.
Study Start Date
August 29, 2018 (Actual)
Primary Completion Date
January 13, 2021 (Actual)
Study Completion Date
January 13, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The investigators found that there is inflammation in the chest drainage in patients after the Fontan operation. The investigators want to test the theory that Colchicine, an anti- inflammatory medication, can decrease the inflammation in the chest tube drainage after the Fontan operation, and can decrease the amount of time that patients having this surgery will have drainage.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Single-ventricle, Heart Diseases
Keywords
Fontan, Colchicine, heart surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Colchicine
Arm Type
Experimental
Arm Description
Colchicine will be given at 0.6 mg once daily for the duration of chest tube output plus 24 hours after chest tube removal with a maximum of 4 weeks duration.
Intervention Type
Drug
Intervention Name(s)
Colchicine
Intervention Description
Colchicine is an alkaloid approved in 1961 for the use in Familial Mediterranean Fever in adults and children 4 years of age or older. It has been widely used for decades in other indications, such as Gout, recurrent pericarditis, pericardial effusions and other inflammatory diseases. This drug is commercially available and is approved in children 4 years and older.
Primary Outcome Measure Information:
Title
Change in Cytokine Total Mass in Pleural Fluid From Patients Treated With Colchicine
Description
Cytokine total mass measured by the Bio-rad Bio-Plex ProHuman Cytokine 17-plex Assay.
Time Frame
Postoperative day 1 ; day most distal from surgery, approximately 7 days after surgery
Title
Difference in Change of Cytokine Concentrations in Pleural Fluid Patients Treated With Colchicine Compared to Historical Controls
Description
Difference is shown via two columns of separate data, but given that enrollment didn't meet target before termination statistical analysis was not done for this measure
Time Frame
Postoperative day 1 ; day most distal from surgery, approximately 7 days after surgery
Secondary Outcome Measure Information:
Title
Cytokine Total Mass as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine
Description
Particularly Cytokine total mass of TNF-α, MIP-1β, IL-8, and IL-10, determined by the Bio-rad Bio-Plex ProHuman Cytokine 17-plex Assay
Data was only collected while patients had chest tubes in place (up to 7 days only)
Time Frame
Postoperative days 1, 2, 3, 4, 7
Title
Difference in Cytokine Total Mass, as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine in Comparison to a Cohort of Postoperative Fontan Patients
Description
Cytokine total mass measured by Bio-rad Bio-Plex ProHuman Cytokine 17-plex Assay
Data was only collected from Colchicine patients while they had chest tubes in place (up to 7 days). For historical controls data was collected up through Day 10
Time Frame
Postoperative days 1, 2, 3, 4, 7, 10
Title
Duration of Pleural Drainage as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine
Description
Duration is measured in days, from date of Fontan surgery to chest tube drainage discontinuation.
Time Frame
Date of chest tube drainage discontinuation, approximately 11 days after surgery
Title
Difference of Duration of Pleural Drainage of Two Groups, in Empiric Treatment With Colchicine Compared to a Cohort of Fontan Patients Not Treated With Colchicine
Description
Duration is measured in days, from date of Fontan surgery to chest tube drainage discontinuation
Time Frame
Date of chest tube drainage discontinuation, approximately 11 days after surgery
Title
Hospital Length of Stay as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine
Description
Measured in days, from date of Fontan surgery to chest tube drainage discontinuation
Time Frame
Hospital discharge at study completion, approximately 2 weeks after surgery
Title
Difference in Hospital Length of Stay
Description
Measured in days compared to historical controls
Time Frame
Hospital discharge at study completion, approximately 2 weeks after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Months
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Ages 20 months to 5 years and 364 days are eligible
Diagnosed with single ventricle heart disease requiring Fontan palliation
Undergoing Fontan palliation at the University of Michigan Congenital Heart Center
Ability to take oral or enteral medication
Exclusion Criteria:
Treatment with another investigational drug within 3 months
Pre-existing myelosuppression or decreased bone marrow activity.
Current or recent treatment with certain drugs
Renal or hepatic impairment deemed by the study team
Conditions and/or post-operative complications that would increase risk to the patient such as mechanical support (ECMO) or issues in the intensive care unit (ICU)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie Goldstein, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Colchicine in Postoperative Fontan Patients
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