Renal Regional Oxygen Saturation During Transcatheter Aortic Valve Implantation
Association of Renal Regional Oxygen Saturation and Postprocedural Acute Kidney Injury in Patients Undergoing Transcatheter Aortic Valve Implantation
1 other identifier
observational
65
1 country
1
Brief Summary
This prospective observational study evaluates the association of peri-procedural changes in renal regional oxygen saturation and post-procedural acute kidney injury in patients undergoing transcatheter aortic valve implantation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 7, 2021
CompletedStudy Start
First participant enrolled
June 7, 2021
CompletedFirst Posted
Study publicly available on registry
June 10, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 27, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 27, 2023
CompletedMay 3, 2023
April 1, 2023
1.7 years
June 7, 2021
April 30, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
acute kidney injury
increase in serum creatinine compared with baseline or reduced urine output
during 7 days post-TAVI
Secondary Outcomes (1)
composite complication
during 7 days post-TAVI or until discharge
Study Arms (1)
Renal regional oxygen saturation
Renal regional oxygen saturation is measured by using near infrared spectroscopy during transcatheter aortic valve implantation
Interventions
Regional oxygen saturation of kidney is monitored using near infrared spectroscopy
Eligibility Criteria
Adult patients (age \>= 20 years) undergoing transfemoral transcatheter aortic valve implantation are eligible for this observational study.
You may qualify if:
- Adult patients (\>= 20 years old) undergoing transcatheter (transfemoral) aortic valve implantation
You may not qualify if:
- Emergent procedure
- Pre-procedural severe renal impairment (eGFR \< 30 mL/min/1.73 m2)
- Pre-procedural hemodialysis
- Distance from skin to renal capsule \> 4 cm
- Pre-procedural mechanical ventilation
- Refuse to participate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, 03080, South Korea
Related Publications (1)
Lee HS, Cho YJ, Yoo S, Lee S, Ju JW, Nam K, Jeon Y. Association of renal regional tissue oxygen saturation and post-procedural acute kidney injury following transcatheter aortic valve implantation. J Clin Monit Comput. 2025 Dec;39(6):1203-1213. doi: 10.1007/s10877-025-01339-2. Epub 2025 Aug 13.
PMID: 40802215DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Youn Joung Cho, MD, PhD
Seoul National University Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Assistant Professor
Study Record Dates
First Submitted
June 7, 2021
First Posted
June 10, 2021
Study Start
June 7, 2021
Primary Completion
February 27, 2023
Study Completion
April 27, 2023
Last Updated
May 3, 2023
Record last verified: 2023-04