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| Name | Class |
|---|---|
| Universitätsmedizin Mannheim | OTHER |
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| kidney transplantation | Experimental | Intravenous injection of Indocyanine Green in patients receiving kidney transplantation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indocyanine green | Drug | perioperative application of Indocyanine green (ICG) |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of intraoperative fluorescence parameters of the ureter with ureter anastomosis complications postoperatively | 24 Months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ulrich Rother, Dr. med. | University of Erlangen, Vascular Surgery | Principal Investigator |
| Kai Nowak, Prof. Dr. med. | University of Mannheim, General Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Erlangen, Vascular Surgery | Erlangen | 91054 | Germany | |||
| University of Mannheim, General Surgery |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33394595 | Derived | Gerken ALH, Nowak K, Meyer A, Weiss C, Kruger B, Nawroth N, Karampinis I, Heller K, Apel H, Reissfelder C, Schwenke K, Keese M, Lang W, Rother U. Quantitative Assessment of Intraoperative Laser Fluorescence Angiography With Indocyanine Green Predicts Early Graft Function After Kidney Transplantation. Ann Surg. 2022 Aug 1;276(2):391-397. doi: 10.1097/SLA.0000000000004529. Epub 2020 Dec 30. |
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| ID | Term |
|---|---|
| D007208 | Indocyanine Green |
| ID | Term |
|---|---|
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| 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 |
| Mannheim |
| 68159 |
| Germany |