NCT05146947

Brief Summary

Intra-operative NIRS measurements of kidney during partial nephrectomy, after reperfusion, for monitoring ischemia and prediction of postoperative renal dysfunction.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2021

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 20, 2021

Completed
11 days until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 7, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2024

Completed
Last Updated

December 7, 2021

Status Verified

December 1, 2021

Enrollment Period

2.1 years

First QC Date

November 20, 2021

Last Update Submit

December 5, 2021

Conditions

Kidney Injury

Outcome Measures

Primary Outcomes (1)

  • Acute Kidney Injury

    An increase in serum creatinine by 0.3mg/dL or more within 48 hours compared with admission creatinine level or an increase in serum creatinine above 1.5 times baseline within 7 days of admission

    7 days post operative and during 6 months post-surgery.

Secondary Outcomes (1)

  • Surgical complications

    7 days post operative

Interventions

near infrared spectroscopyDEVICE

near infrared spectroscopy monitoring on kidney after reperfusion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Candidates for partial nephrectomy at Tel Aviv Medical Center who will consent to participate.

You may not qualify if:

  • Patients unable to give consent,
  • Patients who were lost to follow up during the first 7 post-operative days.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Spectroscopy, Near-Infrared

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisSpectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Orr Goren, Dr

    Tel Aviv Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Orr Goren, Dr

CONTACT

+972527360972org@tlvmc.gov.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2021

First Posted

December 7, 2021

Study Start

December 1, 2021

Primary Completion

December 31, 2023

Study Completion

February 28, 2024

Last Updated

December 7, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share