Measurements of Kidney Perfusion After Transplantation by Intraoperative Fluorescence Angiography
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- Correlation of intraoperative SPY Perfusion Parameters with short-term outcome of the graft function
研究概览
简要总结
Aim of this clinical study is to establish a novel technique, the so called intraoperative fluorescence angiography, for kidney graft perfusion visualization during the transplant procedure.
详细描述
Additional to the common transplant procedure, measurements of the graft perfusion should be established in two ways. Firstly, each kidney should be measured by a common duplex ultrasound measurement to assess the resistance index (RI) in the three poles of the kidney (upper, middle, lower pole). Secondly, intraoperative fluorescence angiography is going to be performed. Therefore, the camera of the fluorescence angiography system (SPY Elite System, Novadaq, USA) is positioned over the organ, and the fluorescence dye (ICG) is applicated intravenously. The aim will be to correlate the fluorescence angiography findings with the RIs and therefore to establish valuable fluorescence parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients receiving kidney transplantation
- •Deceased donor and living donor transplantations
排除标准
- •Allergy against indocyanine green
- •Iodine allergy
- •Contrast allergy
- •Penicillin allergy
- •Allergic diathesis
- •Liver insufficiency
- •Pregnancy
- •Hyperthyreosis
- •Pulmonary arterial hypertension
研究组 & 干预措施
kidney transplantation
Intravenous injection of Indocyanine Green in patients receiving kidney transplantation
干预措施: Indocyanine green (Drug)
结局指标
主要结局
Correlation of intraoperative SPY Perfusion Parameters with short-term outcome of the graft function
时间窗: 24 Months
The intraoperative fluorescence parameters (Ingress, Ingressrate, Egress, Egressrate) will be correlated with the creatinine level of the first 10 postoperative days.
次要结局
- Evaluation of the ideal ICG dosage for intraoperative kidney perfusion(6 Months)
- Correlation of intraoperative measured resistance indices with fluorescence parameters (Ingress, Ingressrate, Egress, Egressrate)(12 Months)
- Correlation of graft rejection episodes and fluorescence parameters(24 Months)
- Correlation of fluorescence parameters with numbers of dialysis needed during the first 10 postoperative days(24 Months)
研究者
Ulrich Rother
Dr. med. Ulrich Rother
University Hospital Erlangen