Kidney Injury, AcuteNCT04921475
Renal Regional Oxygen Saturation During Transcatheter Aortic Valve Implantation
An observational study of Kidney Injury, Acute and Transcatheter Aortic Valve Implantation, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Kidney Injury, Acute, Transcatheter Aortic Valve Implantation
- What is being tested?
- Regional oxygen saturation monitoring
- Type of treatment
- Medical device
- How many people
- 65 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Jun 2021to 27 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients (age >= 20 years) undergoing transfemoral transcatheter aortic valve implantation are eligible for this observational study.
Who may be able to join
- Adult patients (>= 20 years old) undergoing transcatheter (transfemoral) aortic valve implantation
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association of Renal Regional Oxygen Saturation and Postprocedural Acute Kidney Injury in Patients Undergoing Transcatheter Aortic Valve Implantation
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.
Read the detailed description
This prospective observational cohort study evaluated the association of renal regional oxygen saturation, measured during transcatheter aortic valve implantation, and post-procedural acute kidney injury. Renal regional oxygen saturation is measured using near-infrared spectroscopy on the skin surface over the kidneys.
- Being tested
- Regional oxygen saturation monitoring
- Keywords
- renal regional oxygen saturation, acute kidney injury, transcatheter aortic valve implantation
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regional oxygen saturation monitoringDevice
Regional oxygen saturation of kidney is monitored using near infrared spectroscopy
| Study group | Role | What they receive |
|---|---|---|
| Renal regional oxygen saturation | Renal regional oxygen saturation is measured by using near infrared spectroscopy during transcatheter aortic valve implantation Receives: Device: Regional oxygen saturation monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
acute kidney injury
increase in serum creatinine compared with baseline or reduced urine output
Measured: during 7 days post-TAVI
Secondary outcomes (1)
composite complication
stroke, delirium, acute MI, heart failure, new or worsening arrhythmia, mechanical ventilation over 24 h, length of ICU stay, hospital stay, mortality
Measured: during 7 days post-TAVI or until discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study start7 Jun 2021
- Primary completion27 Feb 2023
- Study completion27 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney Injury, AcuteStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Youn Joung Cho, MD, PhD, Seoul National University Hospital
- Investigators
- Youn Joung Cho, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04921475
- Sponsor's protocol ID
- TAVI_renalRSO2
- Status last verified
- Apr 2023
- First submitted
- 7 Jun 2021
- Last updated
- 3 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 40802215
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Renal Regional Oxygen Saturation and Postprocedural Acute Kidney Injury in Patients Undergoing Transcatheter Aortic Valve Implantation
- ClinicalTrials.gov ID
- NCT04921475
- Acronym / sponsor ID
- TAVI_renalRSO2
- Keywords
- renal regional oxygen saturation, acute kidney injury, transcatheter aortic valve implantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 7 Jun 2021 (actual)
- Primary completion
- 27 Feb 2023 (actual)
- Study completion
- 27 Apr 2023 (actual)
- First posted
- 10 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This prospective observational cohort study evaluated the association of renal regional oxygen saturation, measured during transcatheter aortic valve implantation, and post-procedural acute kidney injury. Renal regional oxygen saturation is measured using near-infrared spectroscopy on the skin surface over the kidneys.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Renal regional oxygen saturation | – | Device: Regional oxygen saturation monitoringRenal regional oxygen saturation is measured by using near infrared spectroscopy during transcatheter aortic valve implantation |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (age >= 20 years) undergoing transfemoral transcatheter aortic valve implantation are eligible for this observational study.
Key inclusion criteria (1 listed)
- Adult patients (>= 20 years old) undergoing transcatheter (transfemoral) aortic valve implantation
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Regional oxygen saturation monitoringRegional oxygen saturation of kidney is monitored using near infrared spectroscopy | Device | Renal regional oxygen saturation |
Primary outcome
acute kidney injury
Time frame: during 7 days post-TAVI
increase in serum creatinine compared with baseline or reduced urine output
1 secondary outcome
composite complication
Time frame: during 7 days post-TAVI or until discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
- Derived from this study: PubMed 40802215Lee 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Youn Joung Cho, MD, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Injury, Acute and Transcatheter Aortic Valve Implantation, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
acute kidney injury (time frame: during 7 days post-TAVI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04921475, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2023.