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NCT04685174 Clinical Trial

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

Graft Failure Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04685174
Other study ID # TASMC-20-OG-0143-20-CTIL
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received
Last updated
Start date January 2021
Est. completion date March 2023

Study information
Verified date December 2020
Source Tel-Aviv Sourasky Medical Center
Contact Orr Goren, Dr
Phone +972527360330
Email org@tlvmc.gov.il
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 60
Est. completion date March 2023
Est. primary completion date January 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• Invos Model 5100C Cerebral/Somatic Oximeter
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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Tel-Aviv Sourasky Medical Center

Outcome
Type Measure Description Time frame Safety issue
Primary Graft Failure Initiation of renal replacement therapy 7 days post operative
Primary Graft Failure Initiation of renal replacement therapy 6 months post operative
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