Heart Diseases, Single-ventricle
Conditions
Keywords
Fontan, Colchicine, heart surgery
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.
Interventions
DRUGColchicine
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.
Sponsors
University of Michigan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Months to 5 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 |
| 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 |
Countries
United States
Participant flow
Pre-assignment details
2 people who were consented didn't actually begin the trial. Under the protocol, historical controls were not considered enrolled in this study, so they are not included in participant flow. Historical control data were taken from an observational study with no intervention that was published prior to first enrollment in this trial. Data on the historical controls are available at PMID: 30710164.
Participants by arm
| Arm | Count |
|---|---|
| Colchicine All patients entered the intended protocol where Colchicine was empirically given 0.6mg once daily to postoperative Fontan patients starting on postoperative day 2 and ending 1 day after chest tubes were removed or for a maximum of 4 weeks. | 9 |
| Historical Controls Historical Controls were post-operative Fontan patients who underwent their operation at the University of Michigan. They were part of a prospective observational study that was published in 2019 which included the chest tube drainage sample collection similar to that done with the Colchicine cohort in this trial. | 25 |
| Total | 34 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 2 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Historical Controls | Total | Colchicine |
|---|---|---|---|
| Age, Continuous | 2.5 years | NA years | 2.7 years |
| Primary Diagnosis Hypoplastic left heart syndrome (HLHS) | 14 participants | 20 participants | 6 participants |
| Primary Diagnosis Not HLHS | 11 participants | 14 participants | 3 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) White | 22 Participants | 28 Participants | 6 Participants |
| Region of Enrollment United States | 25 participants | 34 participants | 9 participants |
| Sex: Female, Male Female | 7 Participants | 12 Participants | 5 Participants |
| Sex: Female, Male Male | 18 Participants | 22 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 9 |
| other Total, other adverse events | 9 / 9 |
| serious Total, serious adverse events | 0 / 9 |
Outcome results
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.
Time frame: Postoperative day 1 ; day most distal from surgery, approximately 7 days after surgery
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Colchicine Per Protocol | Change in Cytokine Total Mass in Pleural Fluid From Patients Treated With Colchicine | Interleukin (IL)-8; post op. Day 1 | 60925.8 picograms |
| Colchicine Per Protocol | Change in Cytokine Total Mass in Pleural Fluid From Patients Treated With Colchicine | IL-8, Day 7 | 8684.57 picograms |
| Colchicine Per Protocol | Change in Cytokine Total Mass in Pleural Fluid From Patients Treated With Colchicine | Tumor Necrosis Factor (TNF)-alpha, Day 1 | 6552.7 picograms |
| Colchicine Per Protocol | Change in Cytokine Total Mass in Pleural Fluid From Patients Treated With Colchicine | TNF-alpha, Day 7 | 694.575 picograms |
| Colchicine Per Protocol | Change in Cytokine Total Mass in Pleural Fluid From Patients Treated With Colchicine | Macrophage Inflammatory Protein (MIP)-1 Beta Day 1 | 4949.89 picograms |
| Colchicine Per Protocol | Change in Cytokine Total Mass in Pleural Fluid From Patients Treated With Colchicine | MIP-1 Beta Day 7 | 247.775 picograms |
| Colchicine Per Protocol | Change in Cytokine Total Mass in Pleural Fluid From Patients Treated With Colchicine | Interleukin (IL)-10 Day 1 | 5286.55 picograms |
| Colchicine Per Protocol | Change in Cytokine Total Mass in Pleural Fluid From Patients Treated With Colchicine | IL-10 Day 7 | 132.755 picograms |
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
Time frame: Postoperative day 1 ; day most distal from surgery, approximately 7 days after surgery
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Colchicine Per Protocol | Difference in Change of Cytokine Concentrations in Pleural Fluid Patients Treated With Colchicine Compared to Historical Controls | IL-8 Day 1 | 60925.80 picograms |
| Colchicine Per Protocol | Difference in Change of Cytokine Concentrations in Pleural Fluid Patients Treated With Colchicine Compared to Historical Controls | TNF-ALpha Day 7 | 694.575 picograms |
| Colchicine Per Protocol | Difference in Change of Cytokine Concentrations in Pleural Fluid Patients Treated With Colchicine Compared to Historical Controls | IL-10, Day 1 | 5286.55 picograms |
| Colchicine Per Protocol | Difference in Change of Cytokine Concentrations in Pleural Fluid Patients Treated With Colchicine Compared to Historical Controls | MIP-1 Beta Day 1 | 4949.89 picograms |
| Colchicine Per Protocol | Difference in Change of Cytokine Concentrations in Pleural Fluid Patients Treated With Colchicine Compared to Historical Controls | IL-8 Day 7 | 8684.57 picograms |
| Colchicine Per Protocol | Difference in Change of Cytokine Concentrations in Pleural Fluid Patients Treated With Colchicine Compared to Historical Controls | MIP-1Beta Day 7 | 247.775 picograms |
| Colchicine Per Protocol | Difference in Change of Cytokine Concentrations in Pleural Fluid Patients Treated With Colchicine Compared to Historical Controls | IL-10, Day 7 | 132.755 picograms |
| Colchicine Per Protocol | Difference in Change of Cytokine Concentrations in Pleural Fluid Patients Treated With Colchicine Compared to Historical Controls | TNF-Alpha Day 1 | 6552.70 picograms |
| Historical Controls | Difference in Change of Cytokine Concentrations in Pleural Fluid Patients Treated With Colchicine Compared to Historical Controls | IL-10, Day 7 | 885.04 picograms |
| Historical Controls | Difference in Change of Cytokine Concentrations in Pleural Fluid Patients Treated With Colchicine Compared to Historical Controls | MIP-1Beta Day 7 | 5986.4 picograms |
| Historical Controls | Difference in Change of Cytokine Concentrations in Pleural Fluid Patients Treated With Colchicine Compared to Historical Controls | IL-10, Day 1 | 14474.4 picograms |
| Historical Controls | Difference in Change of Cytokine Concentrations in Pleural Fluid Patients Treated With Colchicine Compared to Historical Controls | IL-8 Day 1 | 83263.45 picograms |
| Historical Controls | Difference in Change of Cytokine Concentrations in Pleural Fluid Patients Treated With Colchicine Compared to Historical Controls | TNF-Alpha Day 1 | 8080.38 picograms |
| Historical Controls | Difference in Change of Cytokine Concentrations in Pleural Fluid Patients Treated With Colchicine Compared to Historical Controls | TNF-ALpha Day 7 | 3320.97 picograms |
| Historical Controls | Difference in Change of Cytokine Concentrations in Pleural Fluid Patients Treated With Colchicine Compared to Historical Controls | MIP-1 Beta Day 1 | 11527.80 picograms |
| Historical Controls | Difference in Change of Cytokine Concentrations in Pleural Fluid Patients Treated With Colchicine Compared to Historical Controls | IL-8 Day 7 | 64695.50 picograms |
Secondary
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
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Colchicine Per Protocol | Cytokine Total Mass as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine | MIP-1 Beta Day 1 | 4949.89 picograms |
| Colchicine Per Protocol | Cytokine Total Mass as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine | IL-8 Day 1 | 60925.80 picograms |
| Colchicine Per Protocol | Cytokine Total Mass as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine | IL 8 Day 2 | 22178.00 picograms |
| Colchicine Per Protocol | Cytokine Total Mass as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine | IL 8 Day 3 | 26837.20 picograms |
| Colchicine Per Protocol | Cytokine Total Mass as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine | IL 8 Day 4 | 50895.36 picograms |
| Colchicine Per Protocol | Cytokine Total Mass as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine | IL 8 Day 7 | 8684.57 picograms |
| Colchicine Per Protocol | Cytokine Total Mass as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine | IL 10 Day 1 | 5286.55 picograms |
| Colchicine Per Protocol | Cytokine Total Mass as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine | IL 10 Day 2 | 2788.44 picograms |
| Colchicine Per Protocol | Cytokine Total Mass as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine | IL 10 Day 3 | 586.50 picograms |
| Colchicine Per Protocol | Cytokine Total Mass as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine | IL 10 Day 4 | 448.06 picograms |
| Colchicine Per Protocol | Cytokine Total Mass as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine | IL 10 Day 7 | 132.755 picograms |
| Colchicine Per Protocol | Cytokine Total Mass as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine | TNF Alpha Day 1 | 6552.70 picograms |
| Colchicine Per Protocol | Cytokine Total Mass as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine | TNF Alpha Day 2 | 6220.50 picograms |
| Colchicine Per Protocol | Cytokine Total Mass as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine | TNF Alpha Day 3 | 3791.84 picograms |
| Colchicine Per Protocol | Cytokine Total Mass as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine | TNF Alpha Day 4 | 2517.90 picograms |
| Colchicine Per Protocol | Cytokine Total Mass as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine | TNF Alpha Day 7 | 694.575 picograms |
| Colchicine Per Protocol | Cytokine Total Mass as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine | MIP-1 Beta Day 2 | 3066.80 picograms |
| Colchicine Per Protocol | Cytokine Total Mass as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine | MIP-1 Beta Day 3 | 4031.04 picograms |
| Colchicine Per Protocol | Cytokine Total Mass as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine | MIP-1 Beta Day 4 | 2730.50 picograms |
| Colchicine Per Protocol | Cytokine Total Mass as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine | MIP-1 Beta Day 7 | 247.775 picograms |
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
Time frame: Postoperative days 1, 2, 3, 4, 7, 10
Population: Day 10 data was not gathered from participants per protocol, but it was available for historical controls.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Colchicine Per Protocol | Difference in Cytokine Total Mass, as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine in Comparison to a Cohort of Postoperative Fontan Patients | IL-10 Day 2 | 2788.440 picograms |
| Colchicine Per Protocol | Difference in Cytokine Total Mass, as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine in Comparison to a Cohort of Postoperative Fontan Patients | TNF Alpha Day 2 | 6220.50 picograms |
| Colchicine Per Protocol | Difference in Cytokine Total Mass, as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine in Comparison to a Cohort of Postoperative Fontan Patients | IL-8 Day 7 | 8684.57 picograms |
| Colchicine Per Protocol | Difference in Cytokine Total Mass, as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine in Comparison to a Cohort of Postoperative Fontan Patients | TNF Alpha Day 3 | 3791.84 picograms |
| Colchicine Per Protocol | Difference in Cytokine Total Mass, as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine in Comparison to a Cohort of Postoperative Fontan Patients | IL-10 Day 3 | 586.59 picograms |
| Colchicine Per Protocol | Difference in Cytokine Total Mass, as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine in Comparison to a Cohort of Postoperative Fontan Patients | TNF Alpha Day 4 | 2517.90 picograms |
| Colchicine Per Protocol | Difference in Cytokine Total Mass, as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine in Comparison to a Cohort of Postoperative Fontan Patients | IL-8 Day 1 | 60925.80 picograms |
| Colchicine Per Protocol | Difference in Cytokine Total Mass, as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine in Comparison to a Cohort of Postoperative Fontan Patients | TNF Alpha Day 7 | 694.575 picograms |
| Colchicine Per Protocol | Difference in Cytokine Total Mass, as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine in Comparison to a Cohort of Postoperative Fontan Patients | IL-10 Day 4 | 448.06 picograms |
| Colchicine Per Protocol | Difference in Cytokine Total Mass, as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine in Comparison to a Cohort of Postoperative Fontan Patients | MIP-Beta Day 1 | 4949.89 picograms |
| Colchicine Per Protocol | Difference in Cytokine Total Mass, as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine in Comparison to a Cohort of Postoperative Fontan Patients | IL-8 Day 4 | 50895.36 picograms |
| Colchicine Per Protocol | Difference in Cytokine Total Mass, as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine in Comparison to a Cohort of Postoperative Fontan Patients | MIP-Beta Day 2 | 3066.80 picograms |
| Colchicine Per Protocol | Difference in Cytokine Total Mass, as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine in Comparison to a Cohort of Postoperative Fontan Patients | IL-10 Day 7 | 132.755 picograms |
| Colchicine Per Protocol | Difference in Cytokine Total Mass, as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine in Comparison to a Cohort of Postoperative Fontan Patients | MIP-Beta Day 3 | 4031.04 picograms |
| Colchicine Per Protocol | Difference in Cytokine Total Mass, as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine in Comparison to a Cohort of Postoperative Fontan Patients | IL-10 Day 1 | 5286.55 picograms |
| Colchicine Per Protocol | Difference in Cytokine Total Mass, as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine in Comparison to a Cohort of Postoperative Fontan Patients | MIP-Beta Day 4 | 2730.50 picograms |
| Colchicine Per Protocol | Difference in Cytokine Total Mass, as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine in Comparison to a Cohort of Postoperative Fontan Patients | IL-8 Day 3 | 26837.20 picograms |
| Colchicine Per Protocol | Difference in Cytokine Total Mass, as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine in Comparison to a Cohort of Postoperative Fontan Patients | MIP-Beta Day 7 | 247.775 picograms |
| Colchicine Per Protocol | Difference in Cytokine Total Mass, as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine in Comparison to a Cohort of Postoperative Fontan Patients | TNF Alpha Day 1 | 6552.70 picograms |
| Colchicine Per Protocol | Difference in Cytokine Total Mass, as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine in Comparison to a Cohort of Postoperative Fontan Patients | IL-8 Day 2 | 22178.00 picograms |
| Historical Controls | Difference in Cytokine Total Mass, as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine in Comparison to a Cohort of Postoperative Fontan Patients | MIP-Beta Day 2 | 8822.96 picograms |
| Historical Controls | Difference in Cytokine Total Mass, as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine in Comparison to a Cohort of Postoperative Fontan Patients | MIP-Beta Day 3 | 6594.00 picograms |
| Historical Controls | Difference in Cytokine Total Mass, as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine in Comparison to a Cohort of Postoperative Fontan Patients | MIP-Beta Day 4 | 7375.96 picograms |
| Historical Controls | Difference in Cytokine Total Mass, as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine in Comparison to a Cohort of Postoperative Fontan Patients | MIP-Beta Day 7 | 5986.40 picograms |
| Historical Controls | Difference in Cytokine Total Mass, as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine in Comparison to a Cohort of Postoperative Fontan Patients | MIP-Beta Day 10 | 8957.13 picograms |
| Historical Controls | Difference in Cytokine Total Mass, as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine in Comparison to a Cohort of Postoperative Fontan Patients | IL-8 Day 2 | 50734.56 picograms |
| Historical Controls | Difference in Cytokine Total Mass, as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine in Comparison to a Cohort of Postoperative Fontan Patients | TNF Alpha Day 7 | 3320.97 picograms |
| Historical Controls | Difference in Cytokine Total Mass, as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine in Comparison to a Cohort of Postoperative Fontan Patients | IL-8 Day 1 | 83263.45 picograms |
| Historical Controls | Difference in Cytokine Total Mass, as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine in Comparison to a Cohort of Postoperative Fontan Patients | IL-8 Day 3 | 36175.15 picograms |
| Historical Controls | Difference in Cytokine Total Mass, as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine in Comparison to a Cohort of Postoperative Fontan Patients | IL-8 Day 4 | 52203.825 picograms |
| Historical Controls | Difference in Cytokine Total Mass, as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine in Comparison to a Cohort of Postoperative Fontan Patients | IL-8 Day 7 | 64695.5 picograms |
| Historical Controls | Difference in Cytokine Total Mass, as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine in Comparison to a Cohort of Postoperative Fontan Patients | IL-8 Day 10 | 140165.900 picograms |
| Historical Controls | Difference in Cytokine Total Mass, as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine in Comparison to a Cohort of Postoperative Fontan Patients | IL-10 Day 1 | 14474.4 picograms |
| Historical Controls | Difference in Cytokine Total Mass, as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine in Comparison to a Cohort of Postoperative Fontan Patients | IL-10 Day 2 | 5341.80 picograms |
| Historical Controls | Difference in Cytokine Total Mass, as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine in Comparison to a Cohort of Postoperative Fontan Patients | IL-10 Day 3 | 1192.29 picograms |
| Historical Controls | Difference in Cytokine Total Mass, as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine in Comparison to a Cohort of Postoperative Fontan Patients | IL-10 Day 4 | 1462.22 picograms |
| Historical Controls | Difference in Cytokine Total Mass, as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine in Comparison to a Cohort of Postoperative Fontan Patients | IL-10 Day 7 | 885.04 picograms |
| Historical Controls | Difference in Cytokine Total Mass, as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine in Comparison to a Cohort of Postoperative Fontan Patients | IL-10 Day 10 | 417.80 picograms |
| Historical Controls | Difference in Cytokine Total Mass, as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine in Comparison to a Cohort of Postoperative Fontan Patients | TNF Alpha Day 1 | 8080.38 picograms |
| Historical Controls | Difference in Cytokine Total Mass, as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine in Comparison to a Cohort of Postoperative Fontan Patients | TNF Alpha Day 2 | 4761.36 picograms |
| Historical Controls | Difference in Cytokine Total Mass, as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine in Comparison to a Cohort of Postoperative Fontan Patients | TNF Alpha Day 3 | 3495.45 picograms |
| Historical Controls | Difference in Cytokine Total Mass, as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine in Comparison to a Cohort of Postoperative Fontan Patients | TNF Alpha Day 4 | 3411.555 picograms |
| Historical Controls | Difference in Cytokine Total Mass, as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine in Comparison to a Cohort of Postoperative Fontan Patients | TNF Alpha Day 10 | 2361.60 picograms |
| Historical Controls | Difference in Cytokine Total Mass, as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine in Comparison to a Cohort of Postoperative Fontan Patients | MIP-Beta Day 1 | 11527.80 picograms |
Secondary
Difference in Hospital Length of Stay
Measured in days compared to historical controls
Time frame: Hospital discharge at study completion, approximately 2 weeks after surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Colchicine Per Protocol | Difference in Hospital Length of Stay | 7 days |
| Historical Controls | Difference in Hospital Length of Stay | 9 days |
| Historical Controls | Difference in Hospital Length of Stay | 11 days |
p-value: 0.005Wilcoxon (Mann-Whitney)
p-value: 0.13Wilcoxon (Mann-Whitney)
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
Time frame: Date of chest tube drainage discontinuation, approximately 11 days after surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Colchicine Per Protocol | 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 | 6 days |
| Historical Controls | 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 | 7.5 days |
| Historical Controls | 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 | 10 days |
p-value: 0.007Wilcoxon (Mann-Whitney)
p-value: 0.17Wilcoxon (Mann-Whitney)
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.
Time frame: Date of chest tube drainage discontinuation, approximately 11 days after surgery
Population: Intention to Treat compared to colchicine per protocol
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Colchicine Per Protocol | Duration of Pleural Drainage as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine | 7.5 days |
| Historical Controls | Duration of Pleural Drainage as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine | 6 days |
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
Time frame: Hospital discharge at study completion, approximately 2 weeks after surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Colchicine Per Protocol | Hospital Length of Stay as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine | 9 days |
| Historical Controls | Hospital Length of Stay as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine | 7 days |