Renal Regional Oxygen Saturation During Transcatheter Aortic Valve Implantation

April 30, 2023 updated by: Youn Joung Cho, MD, PhD, Seoul National University Hospital

Association of Renal Regional Oxygen Saturation and Postprocedural Acute Kidney Injury in Patients Undergoing 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

65

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Adult patients (age >= 20 years) undergoing transfemoral transcatheter aortic valve implantation are eligible for this observational study.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
acute kidney injury
Time Frame: during 7 days post-TAVI
increase in serum creatinine compared with baseline or reduced urine output
during 7 days post-TAVI

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
during 7 days post-TAVI or until discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 7, 2021

Primary Completion (Actual)

February 27, 2023

Study Completion (Actual)

April 27, 2023

Study Registration Dates

First Submitted

June 7, 2021

First Submitted That Met QC Criteria

June 7, 2021

First Posted (Actual)

June 10, 2021

Study Record Updates

Last Update Posted (Actual)

May 3, 2023

Last Update Submitted That Met QC Criteria

April 30, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TAVI_renalRSO2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Kidney Injury, Acute

Clinical Trials on Regional oxygen saturation monitoring

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Morocco

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe