Association Between Renal Resistive Index(RRI) and AKI(Acute Kidney Injury) in Cardiac Surgery Patients With Cardiopulmonary Bypass (CPB)

June 10, 2024 updated by: Yonsei University
AKI(Acute Kidney Injury) is a common complication after cardiac surgery which is associated with increased mortality and morbidity. The conventiional marker for detecting AKI is serum creatinine, however, which has many limits. RRI(Renal Resistive Index) is a non-invasive test measured by ultrasound and could be a useful tool to evaulate renal insult in the early phase. Early detection of renal insult and prevention of progression to AKI can contribute to reduing mortality and morbidity in cardiac surgical patients.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

250

Contacts and Locations

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

Study Contact

  • Name: SUNGMIN SUH, MD
  • Phone Number: 82-10-8916-5701
  • Email: suh5701@yuhs.ac

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Association between renal resistive index(RRI) and AKI(Acute Kidney Injury) in cardiac surgery patients

Description

Inclusion Criteria:

  • Aged 19 years and older scheduled for cardiac surgery using CPB

Exclusion Criteria:

  • Emergency opeartion, pre-operative shock status requiring vasopressor or inotropics, s/p kidney transplant patients, CKD stage 4 and 5 patients, patients who have renal artery stenosis or history of renal artery stent implantation, patients who have ascites with Child-Pugh classification B or C, In case of CPB weaning failure, In case of poor lung function and PaO2 or PaCO2 cannot be maintained within normal range.

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
RRI positive group
RRI value higher than 0.7 measured by renal interlobar artery US
Procedure: Renal interlobar artery US
By using convex US transducer, first find interlobar artery. Then get a pulsed wave doppler at renal interlobar artery for similar 3 to 5 waveforms. Measure peak systolic and minimum diastolic velocity and calculate RRI value.
RRI negative group
RRI value lower than 0.7 measured by renal interlobar artery US
Procedure: Renal inter-lobular artery US
By using convex US transducer, first find interlobar artery. Then get a pulsed wave doppler at renal interlobar artery for similar 3 to 5 waveforms. Measure peak systolic and minimum diastolic velocity and calculate RRI value.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
post-operative AKI incidence
Time Frame: within first 1 week after surgery
The definition of AKI refers to Kidney Disease: Improving Global Outcomes (KDIGO) Acute Kidney Injury Work Group. KDIGO Clinical Practice Guideline for Acute Kidney Injury.
within first 1 week after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major adverse kidney outcome (MAKE) 30
Time Frame: within first 1 month after surgery
MAKE30 includes new dialysis, eGFR decrease more than 25% from the baseline, and mortality
within first 1 month after surgery

Collaborators and Investigators

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

Sponsor

Yonsei University

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 (Estimated)

July 1, 2024

Primary Completion (Estimated)

June 25, 2025

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

June 10, 2024

First Submitted That Met QC Criteria

June 10, 2024

First Posted (Actual)

June 18, 2024

Study Record Updates

Last Update Posted (Actual)

June 18, 2024

Last Update Submitted That Met QC Criteria

June 10, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2024-0439

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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 Acute Kidney Injury

Clinical Trials on Renal interlobar artery US

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ghana

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe