Preoperative RRI and Long-term Risk for CKD

Chronic Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05577039
• Other study ID #: K 2021-9906
• Status: Completed
• Start date: November 1, 2022
• Est. completion date: September 1, 2023

Study information

• Verified date: October 2022
• Source: Region Stockholm
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: September 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Disease
• Acute Kidney Injury
• Cardiac Surgery
• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic
• Renal Resistive Index

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Region Stockholm

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Long-term renal dysfunction	Reduced estimated glomerular filtration rate (eGFR) =25% from baseline	5 years after surgery or end of follow-up
Secondary	Short-term renal dysfunction	Reduced eGFR =25% from baseline	30 days after surgery
Secondary	Intermediate renal dysfunction	Reduced eGFR =25% from baseline	90 days after surgery
Secondary	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
Secondary	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