Intraoperative NIRS of Transplanted Kidney for Prediction... | NCT04685174

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

NCT04685174

Sponsor

Tel-Aviv Sourasky Medical Center

Status

Unknown status

Last Update Posted

Dec 28, 2020Actual

Enrollment

60Estimated

Phase

Phase 3

Conditions

Graft Failure

Interventions

Invos Model 5100C Cerebral/Somatic Oximeter

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2021Estimated

Primary Completion Date

Jan 2023Estimated

Completion Date

Mar 2023Estimated

First Submitted Date

Nov 9, 2020

First Submission Date that Met QC Criteria

Dec 24, 2020

First Posted Date

Dec 28, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 24, 2020

Last Update Posted Date

Dec 28, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Invos Model 5100C Cerebral/Somatic Oximeter	Device	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Graft Failure	Initiation of renal replacement therapy	7 days post operative
Graft Failure	Initiation of renal replacement therapy	6 months post operative

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Orr Goren, Dr	Contact	+972527360330		org@tlvmc.gov.il

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided