Colchicine in Postoperative Fontan Patients

Phase 2

Terminated

• Conditions: Single-ventricle; Heart Diseases
• Interventions: Drug: Colchicine

• Registration Number: NCT03575572
• Lead Sponsor: University of Michigan

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-06-18
• Study First Submitted QC: 2018-06-28
• Study First Posted: 2018-07-02
• Study Start: 2018-08-29
• Primary Completion: 2021-01-13
• Study Completion: 2021-01-13
• Results First Submitted: 2022-02-28
• Status Verified: 2022-04
• Results First Submitted QC: 2022-04-12
• Last Update Submitted: 2022-04-12
• Results First Posted: 2022-05-09
• Last Update Posted: 2022-05-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Colchicine	Colchicine	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.

Primary Outcome Measures

Name	Time	Method
Difference in Change of Cytokine Concentrations in Pleural Fluid Patients Treated With Colchicine Compared to Historical Controls	Postoperative day 1 ; day most distal from surgery, approximately 7 days after surgery	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
Change in Cytokine Total Mass in Pleural Fluid From Patients Treated With Colchicine	Postoperative day 1 ; day most distal from surgery, approximately 7 days after surgery	Cytokine total mass measured by the Bio-rad Bio-Plex ProHuman Cytokine 17-plex Assay.

Secondary Outcome Measures

Name	Time	Method
Duration of Pleural Drainage as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine	Date of chest tube drainage discontinuation, approximately 11 days after surgery	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	Date of chest tube drainage discontinuation, approximately 11 days after surgery	Duration is measured in days, from date of Fontan surgery to chest tube drainage discontinuation
Cytokine Total Mass as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine	Postoperative days 1, 2, 3, 4, 7	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	Postoperative days 1, 2, 3, 4, 7, 10	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
Difference in Hospital Length of Stay	Hospital discharge at study completion, approximately 2 weeks after surgery	Measured in days compared to historical controls
Hospital Length of Stay as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine	Hospital discharge at study completion, approximately 2 weeks after surgery	Measured in days, from date of Fontan surgery to chest tube drainage discontinuation

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States