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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05577039
Other study ID # K 2021-9906
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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