NCT04685174

Brief Summary

This is a prospective, observational cohort study, designed to explore the use of NIRS in kidney transplants. This study will investigate an association between measurements of intra- operative NIRS and post - operative graft dysfunction as manifested in initiation of renal replacement therapy.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2021

Status
unknown

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

First Submitted

Initial submission to the registry

November 9, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 28, 2020

Completed
4 days until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

December 28, 2020

Status Verified

December 1, 2020

Enrollment Period

2 years

First QC Date

November 9, 2020

Last Update Submit

December 24, 2020

Conditions

Graft Failure

Outcome Measures

Primary Outcomes (2)

  • Graft Failure

    Initiation of renal replacement therapy

    7 days post operative

  • Graft Failure

    Initiation of renal replacement therapy

    6 months post operative

Interventions

Invos Model 5100C Cerebral/Somatic OximeterDEVICE

To measure the correlation between post arterial and venous anastomoses (reperfusion) NIRS values of transplanted kidney and post-transplant graft failure as manifested in initiation of renal replacement therapy post transplant

Eligibility Criteria

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

You may qualify if:

  • Kidney transplant candidates (living/ cadaver donor) at TLVMC who will consent to participate.

You may not qualify if:

  • Patients unable to give consent,
  • patients whose surgeries were aborted before transplant,
  • patients who were lost to follow up during the first 7 post-transplant days,
  • patients who suffered from surgical graft failure (vascular problems or need for re exploration due to bleeding etc.)
  • No pregnant patients will participate in this study.
  • No minors will participate in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Orr Goren, Dr

CONTACT

+972527360330org@tlvmc.gov.il

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2020

First Posted

December 28, 2020

Study Start

January 1, 2021

Primary Completion

January 1, 2023

Study Completion

March 1, 2023

Last Updated

December 28, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share