Back to resultsIntraoperative Near Infrared Spectroscopy of Kidney for Prediction of Acute and Sub-acute Kidney Injury in Partial Nephrectomy
Primary Purpose
Kidney Injury
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
near infrared spectroscopy
Sponsored by
About this trial
This is an interventional screening trial for Kidney Injury
Eligibility Criteria
Inclusion Criteria:
- Candidates for partial nephrectomy at Tel Aviv Medical Center who will consent to participate.
Exclusion Criteria:
- Patients unable to give consent,
- Patients who were lost to follow up during the first 7 post-operative days.
Sites / Locations
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Surgical complications
Vascular/Bleeding ect.
Full Information
NCT ID
NCT05146947
First Posted
November 20, 2021
Last Updated
December 5, 2021
Sponsor
Tel-Aviv Sourasky Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT05146947
Brief Title
Intraoperative Near Infrared Spectroscopy of Kidney for Prediction of Acute and Sub-acute Kidney Injury in Partial Nephrectomy
Official Title
Intraoperative Near Infrared Spectroscopy of Kidney for Prediction of Acute and Sub-acute Kidney Injury in Partial Nephrectomy
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2021 (Anticipated)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
February 28, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tel-Aviv Sourasky Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Intra-operative NIRS measurements of kidney during partial nephrectomy, after reperfusion, for monitoring ischemia and prediction of postoperative renal dysfunction.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Injury
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
near infrared spectroscopy
Intervention Description
near infrared spectroscopy monitoring on kidney after reperfusion
Primary Outcome Measure Information:
Title
Acute Kidney Injury
Description
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
Time Frame
7 days post operative and during 6 months post-surgery.
Secondary Outcome Measure Information:
Title
Surgical complications
Description
Vascular/Bleeding ect.
Time Frame
7 days post operative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Candidates for partial nephrectomy at Tel Aviv Medical Center who will consent to participate.
Exclusion Criteria:
Patients unable to give consent,
Patients who were lost to follow up during the first 7 post-operative days.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Orr Goren, Dr
Phone
+972527360972
Email
org@tlvmc.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Orr Goren, Dr
Organizational Affiliation
Tel Aviv Medical Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Intraoperative Near Infrared Spectroscopy of Kidney for Prediction of Acute and Sub-acute Kidney Injury in Partial Nephrectomy
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