Characterizing the Effect of Dopamine on Markers of Lymph Re-circulation in Fontan-associated Protein-losing Enteropathy
Reason given: Inadequate patient enrollment
Key facts
- Where
- Ann Arbor, United StatesSee the site
Where in United States
- University of Michigan Health SystemAnn Arbor, United StatesNo longer taking part
Trial details
- Who runs it
- University of Michigan
- Trial code
- NCT03322345
- Record updated
- 14 July 2026
- Original description
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 suggest PLE is primarily caused by impaired lymph flow. Use of continuous dopamine infusion can improve PLE. Evidence suggests the effect of dopamine may be through its effect on lymphatic function. This observational study looks at markers of lymph flow and PLE symptoms after treatment using dopamine and other standard therapies during disease exacerbations.Read full original descriptionShow less
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 suggest PLE is primarily caused by impaired lymph flow. Use of continuous dopamine infusion can improve PLE. Evidence suggests the effect of dopamine may be through its effect on lymphatic function. This observational study looks at markers of lymph flow and PLE symptoms after treatment using dopamine and other standard therapies during disease exacerbations.
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.