Colchicine in Postoperative Fontan Patients

Study Overview
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Brief Summary
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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.

Official Title
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Colchicine in Postoperative Fontan Patients (CPFP)

Conditions
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Single-ventricle, Heart Diseases

Intervention / Treatment
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* Drug: Colchicine


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 20 Months
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Colchicine<br>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. | Drug: Colchicine<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Postoperative day 1 ; day most distal from surgery, approximately 7 days after surgery | 
| 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 | Postoperative day 1 ; day most distal from surgery, approximately 7 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Postoperative days 1, 2, 3, 4, 7 | 
| 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 | Postoperative days 1, 2, 3, 4, 7, 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. | Date of chest tube drainage discontinuation, approximately 11 days after surgery | 
| 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 | Date of chest tube drainage discontinuation, approximately 11 days after surgery | 
| 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 | Hospital discharge at study completion, approximately 2 weeks after surgery | 
| Difference in Hospital Length of Stay | Measured in days compared to historical controls | Hospital discharge at study completion, approximately 2 weeks after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fontan, Colchicine, heart surgery