Lymphatic Function and Interstitial Fluid Filtration in Patients With a Fontan Circulation From Brazil
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Lymphatic function assessed by Near-Infrared fluorescence Imaging 1
研究概览
简要总结
It is suggested that the elevated central venous pressure in patients with a Fontan circulation can provoke manifestation of lymphatic dysfunction, met as plastic bronchitis, peripheral oedema and most feared protein-losing enteropathy (PLE).
An explorative study from our department at Aarhus University Hospital revealed that the function of the lymphatic vasculature in 10 young Fontan patients with no complications was abnormal compared to healthy controls. However, to further describe and confirm these findings we had to investigate the lymphatic circulation in a larger, older and more complicated group of Fontan patients.
The hypothesis is that, patients with a univentricular circulation have a reduced functionality of the lymphatic vasculature and which predisposes them to developing complications such as edema and PLE.
详细描述
The study population is patients with a Fontan circulation followed at InCor Heart Institute in Sao Paolo and Ribeirão Preto, Brazil. These were matched with and group of healthy controls.
The functional state of superficial lymphatics in the lower leg will be investigated, using near infrared fluorescence (NIRF) imaging. The capillary filtration of fluid and leakiness of the capillaries will be measured using strain gauge plethysmography and the peripheral blood flow will be measured using venous occlusion plethysmography. Furthermore, plasma concentration of noradrenaline will be estimated.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Fontan circulation
- •Age above 16.
排除标准
- •Mental illness
- •Syndromes.
结局指标
主要结局
Lymphatic function assessed by Near-Infrared fluorescence Imaging 1
时间窗: 1 hour
Contraction frequency (contraction/minut)
Lymphatic function assessed by Near-Infrared fluorescence Imaging 2
时间窗: 1 hour
Pumping Pressure (mmHg)
Lymphatic function assessed by Near-Infrared fluorescence Imaging 3
时间窗: 1 hour
Packet Velocity
次要结局
- Capillary Filtration Rate measured by Strain Gauge Plethysmography(1 hour)