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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-31

Study Completion Date

2023-03-31

Brief Summary

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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

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Conditions

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Graft Failure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Orr Goren, Dr

Role: CONTACT

Phone: +972527360330

Email: [email protected]

Other Identifiers

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TASMC-20-OG-0143-20-CTIL

Identifier Type: -

Identifier Source: org_study_id