We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Colchicine in Postoperative Fontan Patients (CPFP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03575572
Recruitment Status : Terminated (Staffing changes impacted by COVID-19 pandemic resulting in inadequate personnel to facilitate study.)
First Posted : July 2, 2018
Results First Posted : May 9, 2022
Last Update Posted : May 9, 2022
Sponsor:
Information provided by (Responsible Party):
Stephanie Goldstein, University of Michigan

Tracking Information
First Submitted Date  ICMJE June 18, 2018
First Posted Date  ICMJE July 2, 2018
Results First Submitted Date  ICMJE February 28, 2022
Results First Posted Date  ICMJE May 9, 2022
Last Update Posted Date May 9, 2022
Actual Study Start Date  ICMJE August 29, 2018
Actual Primary Completion Date January 13, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 12, 2022)
  • Change in Cytokine Total Mass in Pleural Fluid From Patients Treated With Colchicine [ Time Frame: 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 [ Time Frame: 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
Original Primary Outcome Measures  ICMJE
 (submitted: June 28, 2018)
  • Change in Cytokine concentrations in pleural fluid from patients treated with Colchicine [ Time Frame: Postoperative day 1 ; day most distal from surgery, approximately 7 days after surgery ]
    Cytokine concentrations 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 [ Time Frame: Postoperative day 1 ; day most distal from surgery, approximately 7 days after surgery ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 28, 2022)
  • Cytokine Total Mass as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine [ Time Frame: 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 [ Time Frame: 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
  • Duration of Pleural Drainage as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine [ Time Frame: 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 [ Time Frame: 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
  • Hospital Length of Stay as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine [ Time Frame: 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 Hospital Length of Stay [ Time Frame: Hospital discharge at study completion, approximately 2 weeks after surgery ]
    Measured in days compared to historical controls
Original Secondary Outcome Measures  ICMJE
 (submitted: June 28, 2018)
  • Cytokine concentrations as measured in postoperative Fontan patients treated empirically with Colchicine [ Time Frame: Postoperative days 1, 2, 3, 4, 7, 10, 14, 21 and 28 ]
    Particularly Cytokine concentrations of TNF-α, MIP-1βm, IL-17A, IL-8, and INF-γ, determined by the Bio-rad Bio-Plex ProHuman Cytokine 17-plex Assay
  • Difference in Cytokine concentrations, as measured in postoperative Fontan patients treated empirically with Colchicine in comparison to a cohort of postoperative Fontan patients [ Time Frame: Postoperative days 1, 2, 3, 4, 7, 10, 14, 21 and 28 ]
    Concentrations measured by Bio-rad Bio-Plex ProHuman Cytokine 17-plex Assay
  • Duration of pleural drainage as measured in postoperative Fontan patients treated empirically with Colchicine [ Time Frame: 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 [ Time Frame: 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
  • Hospital length of stay as measured in postoperative Fontan patients treated empirically with Colchicine [ Time Frame: 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 hospital length of stay [ Time Frame: Hospital discharge at study completion, approximately 2 weeks after surgery ]
    Measured in days compared to historical controls
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Colchicine in Postoperative Fontan Patients
Official Title  ICMJE Colchicine in Postoperative Fontan Patients (CPFP)
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Single-ventricle
  • Heart Diseases
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: 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.
Intervention: Drug: Colchicine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 11, 2021)
11
Original Estimated Enrollment  ICMJE
 (submitted: June 28, 2018)
25
Actual Study Completion Date  ICMJE January 13, 2021
Actual Primary Completion Date January 13, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Months to 5 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03575572
Other Study ID Numbers  ICMJE HUM00143571
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Stephanie Goldstein, University of Michigan
Original Responsible Party Stephanie Goldstein, University of Michigan, House Officer, Pediatric Cardiology
Current Study Sponsor  ICMJE University of Michigan
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Stephanie Goldstein, MD University of Michigan
PRS Account University of Michigan
Verification Date April 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP