Preoperative RRI and Long-term Risk for CKD

NCT05577039 | Completed

• 1 other identifier: K 2021-9906
• Study Type: observational
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Kidney Injury; Acute Kidney Disease; Chronic Kidney Disease; Cardiac Surgery; Renal Resistive Index

Outcome Measures

Primary Outcomes (1)

• Long-term renal dysfunction

  Reduced estimated glomerular filtration rate (eGFR) ≥25% from baseline

  5 years after surgery or end of follow-up

Secondary Outcomes (4)

• Short-term renal dysfunction

  30 days after surgery

• Intermediate renal dysfunction

  90 days after surgery

• Major adverse kidney events (MAKE)

  30 days, 90 days, 1 year, and 5 years after surgery or end of follow-up

• Major adverse cardiac and cerebrovascular events (MACCE)

  30 days, 90 days, 1 year, and 5 years after surgery or end of follow-up

Eligibility Criteria

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

Study Population

Elective cardiac surgery patients

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Region Stockholm: lead

Study Sites (1)

Karolinska University Hospital

Stockholm, Sweden

Location

MeSH Terms

Conditions

Acute Kidney Injury; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Daniel Hertzberg, M.D.

  Department of Perioperative Medicine and Intensive Care, Karolinska University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 10, 2022
• First Posted: October 13, 2022
• Study Start: November 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: September 1, 2023
• Last Updated: November 24, 2023

Record last verified: 2022-10

Locations

SE (1)