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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04921475
Enrollment
65
Registered
2021-06-10
Start date
2021-06-07
Completion date
2023-04-27
Last updated
2023-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Injury, Acute, Transcatheter Aortic Valve Implantation

Keywords

renal regional oxygen saturation, acute kidney injury, transcatheter aortic valve implantation

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.

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.

Interventions

DEVICERegional oxygen saturation monitoring

Regional oxygen saturation of kidney is monitored using near infrared spectroscopy

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adult patients (\>= 20 years old) undergoing transcatheter (transfemoral) aortic valve implantation

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
acute kidney injuryduring 7 days post-TAVIincrease in serum creatinine compared with baseline or reduced urine output

Secondary

MeasureTime frameDescription
composite complicationduring 7 days post-TAVI or until dischargestroke, delirium, acute MI, heart failure, new or worsening arrhythmia, mechanical ventilation over 24 h, length of ICU stay, hospital stay, mortality

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026