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

NCT06464666 | Not Yet Recruiting DMC

• 1 other identifier: 4-2024-0439
• Study Type: observational
• Target: 250
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Acute Kidney Injury; Renal Resistive Index

Outcome Measures

Primary Outcomes (1)

• post-operative AKI incidence

  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 Outcomes (1)

• Major adverse kidney outcome (MAKE) 30

  within first 1 month after surgery

Study Arms (2)

RRI positive group

RRI value higher than 0.7 measured by renal interlobar artery US

Procedure: Renal interlobar artery US

RRI negative group

RRI value lower than 0.7 measured by renal interlobar artery US

Procedure: Renal inter-lobular artery US

Interventions

Renal interlobar artery US PROCEDURE

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 positive group

Renal inter-lobular artery US PROCEDURE

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

Eligibility Criteria

• Age: 19 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yonsei University: lead

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

SUNGMIN SUH, MD

CONTACT

82-10-8916-5701; suh5701@yuhs.ac

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2024
• First Posted: June 18, 2024
• Study Start: July 1, 2024
• Primary Completion: June 25, 2025
• Study Completion: June 30, 2025
• Last Updated: June 18, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share