Colchicine in Postoperative Fontan Patients

Heart Diseases Clinical Trial

— CPFP  

Official title:

Colchicine in Postoperative Fontan Patients (CPFP)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03575572
• Other study ID #: HUM00143571
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: August 29, 2018
• Est. completion date: January 13, 2021

Study information

• Verified date: April 2022
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: January 13, 2021
• Est. primary completion date: January 13, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Months to 5 Years

Eligibility

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)

Related Conditions & MeSH terms

• Heart Diseases
• Single-ventricle
• Univentricular Heart

Intervention

Drug:
• Colchicine
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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Cytokine Total Mass as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine	Particularly Cytokine total mass of TNF-a, MIP-1ß, 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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Difference in Hospital Length of Stay	Measured in days compared to historical controls	Hospital discharge at study completion, approximately 2 weeks after surgery