Measurements of Kidney Perfusion After Transplantation by Intraoperative Fluorescence Angiography
- Registration Number
- NCT02775838
- Lead Sponsor
- University Hospital Erlangen
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 128
- Patients receiving kidney transplantation
- Deceased donor and living donor transplantations
- Allergy against indocyanine green
- Iodine allergy
- Contrast allergy
- Penicillin allergy
- Allergic diathesis
- Liver insufficiency
- Pregnancy
- Hyperthyreosis
- Pulmonary arterial hypertension
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description kidney transplantation Indocyanine green Intravenous injection of Indocyanine Green in patients receiving kidney transplantation
- Primary Outcome Measures
Name Time Method Correlation of intraoperative SPY Perfusion Parameters with short-term outcome of the graft function 24 Months The intraoperative fluorescence parameters (Ingress, Ingressrate, Egress, Egressrate) will be correlated with the creatinine level of the first 10 postoperative days.
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (2)
University of Erlangen, Vascular Surgery
🇩🇪Erlangen, Germany
University of Mannheim, General Surgery
🇩🇪Mannheim, Germany