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

Acute Kidney Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06464666
• Other study ID #: 4-2024-0439
• Status: Not yet recruiting
• Start date: July 1, 2024
• Est. completion date: June 30, 2025

Study information

• Verified date: June 2024
• Source: Yonsei University
• Contact: SUNGMIN SUH, MD
• Phone: 82-10-8916-5701
• Email: suh5701[@]yuhs.ac
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 250
• Est. completion date: June 30, 2025
• Est. primary completion date: June 25, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Kidney Injury
• Renal Resistive Index
• Wounds and Injuries

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Outcome

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