NCT02775838

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2016

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

April 13, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 18, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

May 8, 2020

Status Verified

May 1, 2020

Enrollment Period

2.7 years

First QC Date

April 13, 2016

Last Update Submit

May 6, 2020

Conditions

Kidney Transplantation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Evaluation of the ideal ICG dosage for intraoperative kidney perfusion

    6 Months

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

    12 Months

  • Correlation of graft rejection episodes and fluorescence parameters

    24 Months

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

    24 Months

Other Outcomes (1)

  • Correlation of intraoperative fluorescence parameters of the ureter with ureter anastomosis complications postoperatively

    24 Months

Study Arms (1)

kidney transplantation

EXPERIMENTAL

Intravenous injection of Indocyanine Green in patients receiving kidney transplantation

Drug: Indocyanine green

Interventions

Indocyanine greenDRUG

perioperative application of Indocyanine green (ICG)

kidney transplantation

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients receiving kidney transplantation
  • Deceased donor and living donor transplantations

You may not qualify if:

  • Allergy against indocyanine green
  • Iodine allergy
  • Contrast allergy
  • Penicillin allergy
  • Allergic diathesis
  • Liver insufficiency
  • Pregnancy
  • Hyperthyreosis
  • Pulmonary arterial hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Erlangen, Vascular Surgery

Erlangen, 91054, Germany

Location

University of Mannheim, General Surgery

Mannheim, 68159, Germany

Location

Related Publications (1)

  • Gerken ALH, Nowak K, Meyer A, Weiss C, Kruger B, Nawroth N, Karampinis I, Heller K, Apel H, Reissfelder C, Schwenke K, Keese M, Lang W, Rother U. Quantitative Assessment of Intraoperative Laser Fluorescence Angiography With Indocyanine Green Predicts Early Graft Function After Kidney Transplantation. Ann Surg. 2022 Aug 1;276(2):391-397. doi: 10.1097/SLA.0000000000004529. Epub 2020 Dec 30.

    PMID: 33394595DERIVED

MeSH Terms

Interventions

Indocyanine Green

Intervention Hierarchy (Ancestors)

IndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Ulrich Rother, Dr. med.

    University of Erlangen, Vascular Surgery

    PRINCIPAL INVESTIGATOR

  • Kai Nowak, Prof. Dr. med.

    University of Mannheim, General Surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. med. Ulrich Rother

Study Record Dates

First Submitted

April 13, 2016

First Posted

May 18, 2016

Study Start

April 1, 2016

Primary Completion

December 1, 2018

Study Completion

January 1, 2019

Last Updated

May 8, 2020

Record last verified: 2020-05

Locations

DE(2)