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NCT Number: NCT04921475

Renal Regional Oxygen Saturation During 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.

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Key information

Conditions

Kidney Injury, Acute Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Transcatheter Aortic Valve Implantation Urogenital Diseases Urologic Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Regional oxygen saturation monitoring

Device

Regional oxygen saturation of kidney is monitored using near infrared spectroscopy

Primary outcomes

  1. acute kidney injury

    Time frame: during 7 days post-TAVI

    increase in serum creatinine compared with baseline or reduced urine output

Secondary outcomes

  1. composite complication

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jun 10, 2021
Registry last updated
May 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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