Measurements of Kidney Perfusion After Transplantation by Intraoperative Fluorescence Angiography

Kidney Transplantation Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02775838
• Other study ID #: SPY-Kidney
• Status: Completed
• Phase: Phase 2
• Start date: April 1, 2016
• Est. completion date: January 1, 2019

Study information

• Verified date: May 2020
• Source: University Hospital Erlangen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: January 1, 2019
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Kidney Transplantation

Intervention

Drug:
• Indocyanine green
perioperative application of Indocyanine green (ICG)

Locations

Country	Name	City	State
Germany	University of Erlangen, Vascular Surgery	Erlangen
Germany	University of Mannheim, General Surgery	Mannheim

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Erlangen	Universitätsmedizin Mannheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Correlation of intraoperative fluorescence parameters of the ureter with ureter anastomosis complications postoperatively		24 Months
Primary	Correlation of intraoperative SPY Perfusion Parameters with short-term outcome of the graft function	The intraoperative fluorescence parameters (Ingress, Ingressrate, Egress, Egressrate) will be correlated with the creatinine level of the first 10 postoperative days.	24 Months
Secondary	Evaluation of the ideal ICG dosage for intraoperative kidney perfusion		6 Months
Secondary	Correlation of intraoperative measured resistance indices with fluorescence parameters (Ingress, Ingressrate, Egress, Egressrate)		12 Months
Secondary	Correlation of graft rejection episodes and fluorescence parameters		24 Months
Secondary	Correlation of fluorescence parameters with numbers of dialysis needed during the first 10 postoperative days		24 Months