Colchicine in Postoperative Fontan Patients

Phase 3TerminatedNCT03575572

University of Michigan11 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Single-ventricle Heart Diseases

Interventions

ColchicineDRUG

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.

Eligibility

Sex: ALLMin age: 20 MonthsMax age: 5 Years

Medical Language ↔ Plain English

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)

Locations (1)

University of Michigan

Ann Arbor, Michigan, United States

Outcomes

Primary Outcomes

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.

Time frame: 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

Time frame: Postoperative day 1 ; day most distal from surgery, approximately 7 days after surgery

Secondary Outcomes

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)

Time frame: 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

Time frame: 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.

Time frame: Date of chest tube drainage discontinuation, approximately 11 days after surgery

Data from ClinicalTrials.gov

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