An observational study in Lymphatic Abnormalities, Lymphatic Edema and Univentricular Heart, sponsored by University of Aarhus. Status unknown. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-12-20.
Sponsored by University of Aarhus · 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.
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.
42 studies on the registry are indexed under Lymphatic Abnormalities; 17 are open to participants now.
This study's enrollment of 10 is below the median of 56 across 13 observational studies indexed under Lymphatic Abnormalities.
Browse Lymphatic Abnormalities studies →University of Aarhus is the lead sponsor of 1,300 studies on the registry; 189 are open to participants now.
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Patients born with an univentricular heart, who surgically is corrected with a Fontan-Kreutzer Circulation
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with a Fontan-Kreutzer circulation. No interventions are done. (The intervention is the operation done 15-20 years ago)
Diagnostic Test: Near Infrared Fluorescence Imaging · Diagnostic Test: Non-contrast MRI · Diagnostic Test: Strain Gauge Plethysmography
Age, gender and weight matched control subjects
Diagnostic Test: Near Infrared Fluorescence Imaging · Diagnostic Test: Non-contrast MRI · Diagnostic Test: Strain Gauge Plethysmography
The functional state of lymphatics is investigated using near infrared fluorescence imaging, NIRF.
Also known as: Strain-Gauge Plethysmography
The anatomy is described using non-contrast MRI.
The capillary filtration rate is measured using plethysmography
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.
Time frame: 1 hour
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.
Time frame: 6 min
Refill time
The time it takes for a 10 cm long vessel to refill after emptying the vessel with massage
Time frame: 20 min
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
Time frame: 6 min
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.
Time frame: 25 min
No study locations are listed for this record.
This study is status unknown, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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