Measurements of Kidney Perfusion After Transplantation by Intraoperative Fluorescence Angiography

University Hospital Erlangen

Status and phase: Completed; Phase 2

Conditions: Kidney Transplantation

Treatments: Drug: Indocyanine green

Study type: Interventional

Funder types: Other

Identifiers

NCT02775838

SPY-Kidney

Details and patient eligibility

About

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.

Full 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.

Enrollment: 128 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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128 participants in 1 patient group

kidney transplantation

Experimental group

Description:

Intravenous injection of Indocyanine Green in patients receiving kidney transplantation

Treatment:

Drug: Indocyanine green