Status:
ENROLLING_BY_INVITATION
Characterizing the Effect of Dopamine on Markers of Lymph Re-circulation in Fontan-associated Protein-losing Enteropathy
Lead Sponsor:
University of Michigan
Conditions:
Dopamine
Protein-Losing Enteropathies
Eligibility:
All Genders
3+ years
Brief Summary
Patients that have undergone a Fontan procedure (surgical correction for single ventricle congenital heart disease) may develop a complication known as protein-losing enteropathy (PLE). Some studies s...
Detailed Description
For infants and newborns who have a heart defect at birth that leaves them with one functional ventricle, there is a series of surgeries that are required to allow survival. These surgeries ultimately...
Eligibility Criteria
Inclusion
- Males and females with Fontan physiology of any age
- Must have protein losing enteropathy with current worsening who require additional therapies
- Participant consent or parental/guardian consent and participant assent
Exclusion
- Patients with inflammatory bowel disease (i.e Crohn's, ulcerative colitis)
- Patients with systemic autoimmune disease (i.e. Systemic Lupus Erythematous)
- Patients with primary immunodeficiency syndromes
- Patients with nephrotic syndrome
- Patients with anemia
- Patients less than 31 pounds
Key Trial Info
Start Date :
April 9 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03322345
Start Date
April 9 2019
End Date
April 1 2027
Last Update
March 13 2025
Active Locations (1)
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1
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109