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Measurements of Kidney Perfusion After Transplantation by Intraoperative Fluorescence Angiography

Sponsor
University Hospital Erlangen (Other)
Overall Status
Completed
CT.gov ID
NCT02775838
Collaborator
Universitätsmedizin Mannheim (Other)
128
Enrollment
2
Locations
1
Arm
33
Actual Duration (Months)
64
Patients Per Site
1.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Indocyanine green
 Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
128 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Actual Study Start Date :
Apr 1, 2016
Actual Primary Completion Date :
Dec 1, 2018
Actual Study Completion Date :
Jan 1, 2019

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

  1. Correlation of intraoperative SPY Perfusion Parameters with short-term outcome of the graft function [24 Months]

    The intraoperative fluorescence parameters (Ingress, Ingressrate, Egress, Egressrate) will be correlated with the creatinine level of the first 10 postoperative days.

Secondary Outcome Measures

  1. Evaluation of the ideal ICG dosage for intraoperative kidney perfusion [6 Months]

  2. Correlation of intraoperative measured resistance indices with fluorescence parameters (Ingress, Ingressrate, Egress, Egressrate) [12 Months]

  3. Correlation of graft rejection episodes and fluorescence parameters [24 Months]

  4. Correlation of fluorescence parameters with numbers of dialysis needed during the first 10 postoperative days [24 Months]

Other Outcome Measures

  1. Correlation of intraoperative fluorescence parameters of the ureter with ureter anastomosis complications postoperatively [24 Months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Erlangen, Vascular Surgery Erlangen Germany 91054
2 University of Mannheim, General Surgery Mannheim Germany 68159

Sponsors and Collaborators

  • University Hospital Erlangen
  • 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ulrich Rother, Dr. med. Ulrich Rother, University Hospital Erlangen
ClinicalTrials.gov Identifier:
NCT02775838
Other Study ID Numbers:
  • SPY-Kidney
First Posted:
May 18, 2016
Last Update Posted:
May 8, 2020
Last Verified:
May 1, 2020

Study Results

No Results Posted as of May 8, 2020