Preoperative RRI and Long-term Risk for CKD

Completed

• Conditions: Acute Kidney Injury; Renal Resistive Index; Acute Kidney Disease; Chronic Kidney Disease; Cardiac Surgery

• Registration Number: NCT05577039
• Lead Sponsor: Region Stockholm

Brief Summary

Renal resistive index (RRI) is calculated from ultrasonographic Doppler measurements of flow velocities in intraparenchymal renal arteries. Normal values are around 0.60, and 0.70 is considered the upper normal threshold in adults. Both preoperative and postoperative elevation of RRI has shown promise in early detection of AKI after cardiac surgery. Further, elevated RRI before coronary angiography is associated with an increased risk of cardiovascular complications up to 1 year after the procedure. The role of preoperative RRI in predicting long-term renal and cardiovascular complications after elective surgery is however not known. The aim of this study is to assess the role of preoperative RRI to predict the risk of persistent renal dysfunction as well as renal- and cardiovascular complications up to 5 years after surgery.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-10
• Study First Submitted: 2022-10-10
• Study First Submitted QC: 2022-10-10
• Study First Posted: 2022-10-13
• Study Start: 2022-11-01
• Primary Completion: 2023-06-01
• Study Completion: 2023-09-01
• Last Update Submitted: 2023-11-21
• Last Update Posted: 2023-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

• Age ≥18
• Elective coronary artery bypass grafting, heart valve surgery, or aortic surgery performed at Karolinska University Hospital between September 2014 and April 2015
• Preoperative measurement of RRI performed with satisfactory Doppler reading
• Written informed consent

Exclusion Criteria

• Kidney transplant
• Dialysis-dependent kidney disease
• Cancelled surgery
• Missing follow-up data

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Long-term renal dysfunction	5 years after surgery or end of follow-up	Reduced estimated glomerular filtration rate (eGFR) ≥25% from baseline

Secondary Outcome Measures

Name	Time	Method
Major adverse cardiac and cerebrovascular events (MACCE)	30 days, 90 days, 1 year, and 5 years after surgery or end of follow-up	Composite outcome during follow-up time including one of; death, myocardial infarction, heart failure, stroke
Intermediate renal dysfunction	90 days after surgery	Reduced eGFR ≥25% from baseline
Major adverse kidney events (MAKE)	30 days, 90 days, 1 year, and 5 years after surgery or end of follow-up	Composite outcome during follow-up time including one of; death, renal replacement therapy, reduced eGFR ≥25% from baseline
Short-term renal dysfunction	30 days after surgery	Reduced eGFR ≥25% from baseline

Trial Locations

Locations (1)

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden