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Completed

NCT Number: NCT02775838

Measurements of Kidney Perfusion After Transplantation by Intraoperative Fluorescence Angiography

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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Key information

Conditions

Kidney Transplantation

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Erlangen, Vascular Surgery, Erlangen, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Indocyanine green

Drug

perioperative application of Indocyanine green (ICG)

Primary outcomes

  1. 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.

Secondary outcomes

  1. Evaluation of the ideal ICG dosage for intraoperative kidney perfusion

    Time frame: 6 Months

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

    Time frame: 12 Months

  3. Correlation of graft rejection episodes and fluorescence parameters

    Time frame: 24 Months

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

    Time frame: 24 Months

Other outcomes

  1. Correlation of intraoperative fluorescence parameters of the ureter with ureter anastomosis complications postoperatively

    Time frame: 24 Months

Sponsors and collaborators

Lead sponsor

University Hospital Erlangen

Other

Collaborators

  • Universitätsmedizin Mannheim

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
May 18, 2016
Registry last updated
May 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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