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NCT05146947 Clinical Trial

Intraoperative Near Infrared Spectroscopy of Kidney for Prediction of Acute and Sub-acute Kidney Injury in Partial Nephrectomy

Kidney Injury Clinical Trial

Official title:
Intraoperative Near Infrared Spectroscopy of Kidney for Prediction of Acute and Sub-acute Kidney Injury in Partial Nephrectomy

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05146947
Other study ID # TASMC-21-OG-0327-21-CTIL
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date December 1, 2021
Est. completion date February 28, 2024

Study information
Verified date December 2021
Source Tel-Aviv Sourasky Medical Center
Contact Orr Goren, Dr
Phone +972527360972
Email org@tlvmc.gov.il
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 90
Est. completion date February 28, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• near infrared spectroscopy
near infrared spectroscopy monitoring on kidney after reperfusion

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Tel-Aviv Sourasky Medical Center

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Surgical complications Vascular/Bleeding ect. 7 days post operative
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