Intraoperative NIRS of Transplanted Kidney for Prediction of Acute and Sub-acute Injury

December 24, 2020 updated by: Tel-Aviv Sourasky Medical Center

Intraoperative Near Infrared Spectroscopy of Transplanted Kidney for Prediction of Acute and Sub-acute Kidney Injury in Transplanted Patients

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.

Study Overview

Status

Not yet recruiting

Conditions

Graft Failure

Intervention / Treatment

Device: Invos Model 5100C Cerebral/Somatic Oximeter

Study Type

Interventional

Enrollment (Anticipated)

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Orr Goren, Dr
Phone Number: +972527360330
Email: org@tlvmc.gov.il

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: DIAGNOSTIC
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Graft Failure Time Frame: 7 days post operative	Initiation of renal replacement therapy	7 days post operative
Graft Failure Time Frame: 6 months post operative	Initiation of renal replacement therapy	6 months post operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tel-Aviv Sourasky Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

January 1, 2021

Primary Completion (ANTICIPATED)

January 1, 2023

Study Completion (ANTICIPATED)

March 1, 2023

Study Registration Dates

First Submitted

November 9, 2020

First Submitted That Met QC Criteria

December 24, 2020

First Posted (ACTUAL)

December 28, 2020

Study Record Updates

Last Update Posted (ACTUAL)