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

Tel Aviv Sourasky Medical Center

Status and phase: Unknown; Phase 3

Conditions: Graft Failure

Treatments: Device: Invos Model 5100C Cerebral/Somatic Oximeter

Study type: Interventional

Funder types: Other

Identifiers

NCT04685174

TASMC-20-OG-0143-20-CTIL

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)