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NCT04921475 Clinical Trial

Renal Regional Oxygen Saturation During Transcatheter Aortic Valve Implantation

Transcatheter Aortic Valve Implantation Clinical Trial

Official title:
Association of Renal Regional Oxygen Saturation and Postprocedural Acute Kidney Injury in Patients Undergoing Transcatheter Aortic Valve Implantation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04921475
Other study ID # TAVI_renalRSO2
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 7, 2021
Est. completion date April 27, 2023

Study information
Verified date April 2023
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 65
Est. completion date April 27, 2023
Est. primary completion date February 27, 2023
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Regional oxygen saturation monitoring
Regional oxygen saturation of kidney is monitored using near infrared spectroscopy

Locations
Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary acute kidney injury increase in serum creatinine compared with baseline or reduced urine output during 7 days post-TAVI
Secondary composite complication stroke, delirium, acute MI, heart failure, new or worsening arrhythmia, mechanical ventilation over 24 h, length of ICU stay, hospital stay, mortality during 7 days post-TAVI or until discharge
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