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Completed

NCT Number: NCT05577039

Preoperative RRI and Long-term Risk for CKD

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.

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Key information

Conditions

Acute Kidney Injury Acute Kidney Disease Cardiac Surgery Chronic Disease Chronic Kidney Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Renal Resistive Index Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Karolinska University Hospital

Stockholm, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Long-term renal dysfunction

    Time frame: 5 years after surgery or end of follow-up

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

Secondary outcomes

  1. Short-term renal dysfunction

    Time frame: 30 days after surgery

    Reduced eGFR ≥25% from baseline

  2. Intermediate renal dysfunction

    Time frame: 90 days after surgery

    Reduced eGFR ≥25% from baseline

  3. Major adverse kidney events (MAKE)

    Time frame: 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

  4. Major adverse cardiac and cerebrovascular events (MACCE)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Region Stockholm

Other Gov

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 13, 2022
Registry last updated
Nov 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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