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Lymphatic Function in Patients With a Fontan-Kreutzer Circulation

The Lymphatic Morphology and Function of Fontan-Kreutzer Operated Patients

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03379805
Enrollment
10
Registered
2017-12-20
Start date
2014-04-25
Completion date
2018-08-31
Last updated
2017-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphatic Abnormalities, Lymphatic Edema, Univentricular Heart

Brief summary

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.

Detailed description

Background: 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. Hypothesis: Patients with a univentricular circulation have a reduced functionality of the lymphatic vasculature, which predisposes them to developing complications such as edema and PLE. Material and Methods: 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. The study population is patients with Fontan-Kreutzer circulation operated at Aarhus University hospital. Exclusion criteria is BMI\>30 and age (years) \< 18. The Fontan-Kreutzer group will be compared with an age, gender and weight matched control group of healthy volunteers.

Interventions

DIAGNOSTIC_TESTNear Infrared Fluorescence Imaging

The functional state of lymphatics is investigated using near infrared fluorescence imaging, NIRF.

DIAGNOSTIC_TESTNon-contrast MRI

The anatomy is described using non-contrast MRI.

The capillary filtration rate is measured using plethysmography

Sponsors

University of Aarhus
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Fontan-Kreutzer circulation

Exclusion criteria

* BMI\>30, * Age\<18 * Mental illness

Design outcomes

Primary

MeasureTime frameDescription
Pumping pressure1 hourOcclusion 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.
Contraction Frequency6 minContraction frequency in vessels in the main drainage pathway of the legs (ventromedial bundle) as well as vessels draining the area behind the medial malleolus.
Refill time20 minThe time it takes for a 10 cm long vessel to refill after emptying the vessel with massage
Velocity6 minThe 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
Capillary Filtration Rate25 minA 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026