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Lymphatic Function in Patients With a Fontan-Kreutzer Circulation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03379805
Recruitment Status : Unknown
Verified December 2017 by University of Aarhus.
Recruitment status was:  Active, not recruiting
First Posted : December 20, 2017
Last Update Posted : December 20, 2017
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

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.


Condition or disease Intervention/treatment
Lymphatic Abnormalities Lymphatic Edema Univentricular Heart Diagnostic Test: Near Infrared Fluorescence Imaging Diagnostic Test: Non-contrast MRI Diagnostic Test: Strain Gauge 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.

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Study Type : Observational
Actual Enrollment : 10 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: The Lymphatic Morphology and Function of Fontan-Kreutzer Operated Patients
Actual Study Start Date : April 25, 2014
Actual Primary Completion Date : June 20, 2017
Estimated Study Completion Date : August 31, 2018


Group/Cohort Intervention/treatment
Fontan-Kreutzer operated patients
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
The functional state of lymphatics is investigated using near infrared fluorescence imaging, NIRF.
Other Name: Strain-Gauge Plethysmography

Diagnostic Test: Non-contrast MRI
The anatomy is described using non-contrast MRI.

Diagnostic Test: Strain Gauge Plethysmography
The capillary filtration rate is measured using plethysmography

Healthy Control subjects
Age, gender and weight matched control subjects
Diagnostic Test: Near Infrared Fluorescence Imaging
The functional state of lymphatics is investigated using near infrared fluorescence imaging, NIRF.
Other Name: Strain-Gauge Plethysmography

Diagnostic Test: Non-contrast MRI
The anatomy is described using non-contrast MRI.

Diagnostic Test: Strain Gauge Plethysmography
The capillary filtration rate is measured using plethysmography




Primary Outcome Measures :
  1. Pumping pressure [ Time Frame: 1 hour ]
    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.

  2. Contraction Frequency [ Time Frame: 6 min ]
    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.

  3. Refill time [ Time Frame: 20 min ]
    The time it takes for a 10 cm long vessel to refill after emptying the vessel with massage

  4. Velocity [ Time Frame: 6 min ]
    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

  5. Capillary Filtration Rate [ Time Frame: 25 min ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients born with an univentricular heart, who surgically is corrected with a Fontan-Kreutzer Circulation
Criteria

Inclusion Criteria:

  • Fontan-Kreutzer circulation

Exclusion Criteria:

  • BMI>30,
  • Age<18
  • Mental illness

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03379805


Sponsors and Collaborators
University of Aarhus
Investigators
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Principal Investigator: Vibeke E Hjortdal, MD, PhD, Dr.Med Aarhus University Hospital, Department of Cardiothoracic and Vascular Surgery

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT03379805    
Other Study ID Numbers: Fontan17
First Posted: December 20, 2017    Key Record Dates
Last Update Posted: December 20, 2017
Last Verified: December 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphatic Abnormalities
Congenital Abnormalities
Lymphatic Diseases