Univentricular Heart Clinical Trial
Official title:
The Lymphatic Morphology and Function of Fontan-Kreutzer Operated Patients
Verified date | December 2017 |
Source | University of Aarhus |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The lymphatics regulate the interstitial fluid by removing excessive fluid. It represents an
extremely important step in the prevention of edema. The Fontan-Kreutzer procedure has
revolutionized the treatment of univentricular hearts. However, it is associated with severe
complications such as protein-losing enteropathy (PLE) and peripheral edema that may involve
the lymphatic circulation.
Our hypothesis is that patients with a univentricular circulation have a reduced
functionality of the lymphatic vasculature, which predisposes them to developing
complications such as edema and PLE.
The functional state of lymphatics is investigated using near infrared fluorescence imaging,
NIRF. The anatomy is described using non-contrast MRI and the capillary filtration rate is
measured using plethysmography.
Status | Active, not recruiting |
Enrollment | 10 |
Est. completion date | August 31, 2018 |
Est. primary completion date | June 20, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Fontan-Kreutzer circulation Exclusion Criteria: - BMI>30, - Age<18 - Mental illness |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Aarhus |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pumping pressure | Occlusion of lymphatic flow by inflating a cuff (Hokanson E20 Rapid cuff inflator, Hokanson AG101 air source) to 70mmHg and then reducing the pressure with 5mmHg each 5th minute. The highest pressure under which the fluorescent dye is able to cross the inflatable cuff is labelled Ppump. | 1 hour | |
Primary | Contraction Frequency | Contraction frequency in vessels in the main drainage pathway of the legs (ventromedial bundle) as well as vessels draining the area behind the medial malleolus. | 6 min | |
Primary | Refill time | The time it takes for a 10 cm long vessel to refill after emptying the vessel with massage | 20 min | |
Primary | Velocity | The velocity measured in cm/s for a packet of lymph moving from one region of interest (ROI) to another through atlas a 5 cm straight vessel | 6 min | |
Primary | Capillary Filtration Rate | A 5-step 20-min venous congestion protocol will be used to measure capillary filtration. The capillary filtration rate (µl·100 ml-1 ·min-1 ) is measured as the slope of the time-volume change (%) curve at steady state at the end of each pressure phase. | 25 min |
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