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

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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04685174
Enrollment
60
Registered
2020-12-28
Start date
2021-01-31
Completion date
2023-03-31
Last updated
2020-12-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Graft Failure

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.

Interventions

DEVICEInvos 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

Sponsors

Tel-Aviv Sourasky Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Graft Failure7 days post operativeInitiation of renal replacement therapy

Contacts

Primary ContactOrr Goren, Dr
org@tlvmc.gov.il+972527360330

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026