Measurements of Kidney Perfusion After Transplantation by Intraoperative Fluorescence Angiography

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-01

Study Completion Date

2019-01-01

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.

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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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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kidney transplantation

Intravenous injection of Indocyanine Green in patients receiving kidney transplantation

Group Type EXPERIMENTAL

Indocyanine green

Intervention Type DRUG

perioperative application of Indocyanine green (ICG)

Interventions

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Indocyanine green

perioperative application of Indocyanine green (ICG)

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No