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

Phase 3

• Conditions: Graft Failure

• Registration Number: NCT04685174
• Lead Sponsor: Tel-Aviv Sourasky Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-09
• Status Verified: 2020-12
• Study First Submitted QC: 2020-12-24
• Last Update Submitted: 2020-12-24
• Study First Posted: 2020-12-28
• Last Update Posted: 2020-12-28
• Study Start: 2021-01
• Primary Completion: 2023-01
• Study Completion: 2023-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Graft Failure	6 months post operative	Initiation of renal replacement therapy