Renal Regional Oxygen Saturation During Transcatheter Aortic Valve Implantation

• Sponsor: Seoul National University Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04921475
• Collaborator: (none)
• Enrollment: 65
• Location: 1
• Anticipated Duration (Months): 24
• Patients Per Site Per Month: 2.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Kidney Injury, Acute; Transcatheter Aortic Valve Implantation	Device: Regional oxygen saturation monitoring

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

• Study Type: Observational
• Anticipated Enrollment: 65 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Association of Renal Regional Oxygen Saturation and Postprocedural Acute Kidney Injury in Patients Undergoing Transcatheter Aortic Valve Implantation
• Actual Study Start Date: Jun 7, 2021
• Anticipated Primary Completion Date: Jun 7, 2023
• Anticipated Study Completion Date: Jun 7, 2023

Arms and Interventions

Arm	Intervention/Treatment
Renal regional oxygen saturation Renal regional oxygen saturation is measured by using near infrared spectroscopy during transcatheter aortic valve implantation	Device: Regional oxygen saturation monitoring; Regional oxygen saturation of kidney is monitored using near infrared spectroscopy

Outcome Measures

Primary Outcome Measures

1. acute kidney injury [during 7 days post-TAVI]

   increase in serum creatinine compared with baseline or reduced urine output

Secondary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul		Korea, Republic of	03080

Sponsors and Collaborators

• Seoul National University Hospital

Investigators

• Principal Investigator: Youn Joung Cho, MD, PhD, Seoul National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Youn Joung Cho, MD, Clinical Assistant Professor, Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT04921475
• Other Study ID Numbers: TAVI_renalRSO2
• First Posted: Jun 10, 2021
• Last Update Posted: Jun 10, 2021
• Last Verified: Jun 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Youn Joung Cho, MD, Clinical Assistant Professor, Seoul National University Hospital: renal regional oxygen saturation; acute kidney injury; transcatheter aortic valve implantation
• Additional relevant MeSH terms: Acute Kidney Injury

Study Results

No Results Posted as of Jun 10, 2021