Preoperative RRI and Long-term Risk for CKD

Preoperative Renal Resistive Index to Predict Long-term Development of Chronic Kidney Disease in Patients Undergoing Cardiac Surgery

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Kidney Disease; Acute Kidney Injury; Cardiac Surgery; Acute Kidney Disease; Renal Resistive Index

• Study Type: Observational
• Enrollment (Anticipated): 96

Contacts and Locations

• Study Contact: Name: Daniel Hertzberg, M.D., Ph.D.; Phone Number: +46 8 123 70000; Email: daniel.hertzberg@ki.se
• Study Contact Backup: Name: Mårten Renberg, M.D.; Phone Number: +46 8 123 70000; Email: marten.renberg@regionstockholm.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Elective cardiac surgery patients

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Region Stockholm
• Investigators: Principal Investigator: Daniel Hertzberg, M.D., Department of Perioperative Medicine and Intensive Care, Karolinska University Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2023
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: October 10, 2022
• First Submitted That Met QC Criteria: October 10, 2022
• First Posted (Actual): October 13, 2022

Study Record Updates

• Last Update Posted (Actual): October 13, 2022
• Last Update Submitted That Met QC Criteria: October 10, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic; Acute Kidney Injury
• Other Study ID Numbers: K 2021-9906

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
• product manufactured in and exported from the U.S.: No