Clinical trial NCT03575572: Colchicine in Postoperative Fontan Patients
Official title: Colchicine in Postoperative Fontan Patients (CPFP)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Single-ventricle
Heart Diseases
Keywords: Fontan
Colchicine
heart surgery
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2018-07-02
Enrollment: 11
Sex: ALL
Minimum age (years): 20
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Change in Cytokine Total Mass in Pleural Fluid From Patients Treated With Colchicine
timeFrame: Postoperative day 1 ; day most distal from surgery, approximately 7 days after surgery
measure: Difference in Change of Cytokine Concentrations in Pleural Fluid Patients Treated With Colchicine Compared to Historical Controls
timeFrame: Postoperative day 1 ; day most distal from surgery, approximately 7 days after surgery
Secondary outcomes:
measure: Cytokine Total Mass as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine
timeFrame: Postoperative days 1, 2, 3, 4, 7
measure: Difference in Cytokine Total Mass, as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine in Comparison to a Cohort of Postoperative Fontan Patients
timeFrame: Postoperative days 1, 2, 3, 4, 7, 10
measure: Duration of Pleural Drainage as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine
timeFrame: Date of chest tube drainage discontinuation, approximately 11 days after surgery
measure: 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
timeFrame: Date of chest tube drainage discontinuation, approximately 11 days after surgery
measure: Hospital Length of Stay as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine
timeFrame: Hospital discharge at study completion, approximately 2 weeks after surgery
measure: Difference in Hospital Length of Stay
timeFrame: Hospital discharge at study completion, approximately 2 weeks after surgery
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Stephanie Goldstein, MD
role: PRINCIPAL_INVESTIGATOR
References: