Measurements of Kidney Perfusion After Transplantation by Intraoperative Fluorescence Angiography

Study Overview
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Brief Summary
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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
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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.

Conditions
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Kidney Transplantation

Intervention / Treatment
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* Drug: Indocyanine green


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: kidney transplantation<br>Intravenous injection of Indocyanine Green in patients receiving kidney transplantation | Drug: Indocyanine green<br>* perioperative application of Indocyanine green (ICG)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of intraoperative SPY Perfusion Parameters with short-term outcome of the graft function | The intraoperative fluorescence parameters (Ingress, Ingressrate, Egress, Egressrate) will be correlated with the creatinine level of the first 10 postoperative days. | 24 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |