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

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

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

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

No

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)

December 28, 2020

Last Update Submitted That Met QC Criteria

December 24, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • TASMC-20-OG-0143-20-CTIL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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