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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

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.

Condition or disease Intervention/treatment Phase
Single-ventricle Heart Diseases Drug: Colchicine Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Colchicine in Postoperative Fontan Patients (CPFP)
Actual Study Start Date : August 29, 2018
Actual Primary Completion Date : January 13, 2021
Actual Study Completion Date : January 13, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Colchicine

Arm Intervention/treatment
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.
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.




Primary Outcome Measures :
  1. 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.

  2. 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


Secondary Outcome Measures :
  1. 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)


  2. 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


  3. 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.

  4. 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

  5. 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

  6. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Months to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03575572


Locations
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United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
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Principal Investigator: Stephanie Goldstein, MD University of Michigan
  Study Documents (Full-Text)

Documents provided by Stephanie Goldstein, University of Michigan:
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Responsible Party: Stephanie Goldstein, House Officer, Pediatric Cardiology and House Officer, Pediatric Critical Care (during active trial status), University of Michigan
ClinicalTrials.gov Identifier: NCT03575572    
Other Study ID Numbers: HUM00143571
First Posted: July 2, 2018    Key Record Dates
Results First Posted: May 9, 2022
Last Update Posted: May 9, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Stephanie Goldstein, University of Michigan:
Fontan
Colchicine
heart surgery
Additional relevant MeSH terms:
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Heart Diseases
Univentricular Heart
Cardiovascular Diseases
Heart Defects, Congenital
Cardiovascular Abnormalities
Congenital Abnormalities
Colchicine
Gout Suppressants
Antirheumatic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents