Renal Regional Oxygen Saturation During Transcatheter Aortic Valve Implantation

Completed

• Conditions: Kidney Injury, Acute; Transcatheter Aortic Valve Implantation
• Interventions: Device: Regional oxygen saturation monitoring

• Registration Number: NCT04921475
• Lead Sponsor: Seoul National University Hospital

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.

Study Timeline

• Study Start: 2021-06-07
• Study First Submitted: 2021-06-07
• Study First Submitted QC: 2021-06-07
• Study First Posted: 2021-06-10
• Primary Completion: 2023-02-27
• Status Verified: 2023-04
• Study Completion: 2023-04-27
• Last Update Submitted: 2023-04-30
• Last Update Posted: 2023-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Renal regional oxygen saturation	Regional oxygen saturation monitoring	Renal regional oxygen saturation is measured by using near infrared spectroscopy during transcatheter aortic valve implantation

Primary Outcome Measures

Name	Time	Method
acute kidney injury	during 7 days post-TAVI	increase in serum creatinine compared with baseline or reduced urine output

Secondary Outcome Measures

Name	Time	Method
composite complication	during 7 days post-TAVI or until discharge	stroke, delirium, acute MI, heart failure, new or worsening arrhythmia, mechanical ventilation over 24 h, length of ICU stay, hospital stay, mortality

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of