By InvitationNot Applicable

Characterizing the Effect of Dopamine on Markers of Lymph Re-circulation in Fontan-associated Protein-losing Enteropathy

United States24 participantsStarted 2019-04-09

Plain-language 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 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.

Who can participate

Age range3 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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

What they're measuring

Change in CD4 counts

Timeframe: Baseline to 6 months

Change in fatty acid profile

Timeframe: Baseline to 6 months

Change in vitamin D3

Timeframe: Baseline to 6 months

Trial details

NCT IDNCT03322345

SponsorUniversity of Michigan

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-04-01

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