Clinical trial NCT02775838: Measurements of Kidney Perfusion After Transplantation by Intraoperative Fluorescence Angiography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Kidney Transplantation
Lead sponsor: University Hospital Erlangen
Sponsor class: OTHER
Collaborators: name: Universitätsmedizin Mannheim
First posted: 2016-05-18
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Correlation of intraoperative SPY Perfusion Parameters with short-term outcome of the graft function
timeFrame: 24 Months
Secondary outcomes:
measure: Evaluation of the ideal ICG dosage for intraoperative kidney perfusion
timeFrame: 6 Months
measure: Correlation of intraoperative measured resistance indices with fluorescence parameters (Ingress, Ingressrate, Egress, Egressrate)
timeFrame: 12 Months
measure: Correlation of graft rejection episodes and fluorescence parameters
timeFrame: 24 Months
measure: Correlation of fluorescence parameters with numbers of dialysis needed during the first 10 postoperative days
timeFrame: 24 Months
Other outcomes:
measure: Correlation of intraoperative fluorescence parameters of the ureter with ureter anastomosis complications postoperatively
timeFrame: 24 Months
Locations:
city: Erlangen
country: Germany
facility: University of Erlangen, Vascular Surgery
city: Mannheim
country: Germany
facility: University of Mannheim, General Surgery
Study officials:
affiliation: University of Erlangen, Vascular Surgery
name: Ulrich Rother, Dr. med.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Mannheim, General Surgery
name: Kai Nowak, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.