Kidney Transplantation
Conditions
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.
Interventions
DRUGIndocyanine green
perioperative application of Indocyanine green (ICG)
Sponsors
Universitätsmedizin Mannheim
University Hospital Erlangen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Patients receiving kidney transplantation * Deceased donor and living donor transplantations
Exclusion criteria
* Allergy against indocyanine green * Iodine allergy * Contrast allergy * Penicillin allergy * Allergic diathesis * Liver insufficiency * Pregnancy * Hyperthyreosis * Pulmonary arterial hypertension
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Other
| Measure | Time frame |
|---|---|
| Correlation of intraoperative fluorescence parameters of the ureter with ureter anastomosis complications postoperatively | 24 Months |
Countries
Germany
Outcome results
None listed