Measurements of Kidney Perfusion After Transplantation by Intraoperative Fluorescence Angiography

May 6, 2020 updated by: Ulrich Rother, University Hospital Erlangen
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

128

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Erlangen, Germany, 91054
        • University of Erlangen, Vascular Surgery
      • Mannheim, Germany, 68159
        • University of Mannheim, General Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of intraoperative SPY Perfusion Parameters with short-term outcome of the graft function
Time Frame: 24 Months
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
Time Frame
Evaluation of the ideal ICG dosage for intraoperative kidney perfusion
Time Frame: 6 Months
6 Months
Correlation of intraoperative measured resistance indices with fluorescence parameters (Ingress, Ingressrate, Egress, Egressrate)
Time Frame: 12 Months
12 Months
Correlation of graft rejection episodes and fluorescence parameters
Time Frame: 24 Months
24 Months
Correlation of fluorescence parameters with numbers of dialysis needed during the first 10 postoperative days
Time Frame: 24 Months
24 Months

Other Outcome Measures

Outcome Measure
Time Frame
Correlation of intraoperative fluorescence parameters of the ureter with ureter anastomosis complications postoperatively
Time Frame: 24 Months
24 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Erlangen

Collaborators

Universitätsmedizin Mannheim

Investigators

  • Principal Investigator: Ulrich Rother, Dr. med., University of Erlangen, Vascular Surgery
  • Principal Investigator: Kai Nowak, Prof. Dr. med., University of Mannheim, General Surgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2016

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

January 1, 2019

Study Registration Dates

First Submitted

April 13, 2016

First Submitted That Met QC Criteria

May 14, 2016

First Posted (Estimate)

May 18, 2016

Study Record Updates

Last Update Posted (Actual)

May 8, 2020

Last Update Submitted That Met QC Criteria

May 6, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • SPY-Kidney

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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