Contrast RISK (Reducing Injury Sustained by Kidneys)

Not Applicable

Completed

• Conditions: Acute Kidney Injury (Nontraumatic); Coronary Artery Disease
• Interventions: Other: Control; Other: Intervention

• Registration Number: NCT03453996
• Lead Sponsor: University of Calgary

Brief Summary

Diagnostic and therapeutic cardiac catheterization procedures are important interventions to reduce the risk of death, avoid future cardiovascular events, and improve quality of life of people with heart disease. However, exposure to the radiocontrast dyes required for these procedures can lead to contrast-induced acute kidney injury (CI-AKI); a common and costly complication. There are accurate ways to identify patients at increased risk of this complication and strategies to prevent CI-AKI. This involves ensuring that patients who are at risk have procedures done with the minimum amount of X-ray contrast dye required, and that they receive optimal intravenous fluids at the time of the procedure.

This study will evaluate the implementation of a strategy where computerized decision support tools are used to help doctors identify patients at risk of CI-AKI, as well as make decisions about how much contrast dye to use and how much intravenous fluid to provide to patients who are identified at risk of CI-AKI in cardiac catheterization.

Detailed Description

Overview: Randomized stepped-wedge trial to evaluate the impact of implementing a computerized decision support strategy that incorporates CI-AKI risk prediction and calculation of safe contrast dye limits and intravenous fluid recommendations.

Study Population: Adult patients undergoing diagnostic or interventional coronary angiography procedures will be eligible if not already receiving dialysis. Patients receiving emergency primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction will be excluded.

Intervention: Multivariable clinical risk prediction model to estimate risk of CI-AKI and safe contrast limits for patients above the median (\>5%) predicted risk of CI-AKI. Intravenous fluids recommendations based on weight and left-ventricular end-diastolic pressure will also be provided for patients identified above the median risk of CI-AKI.

The National Cardiovascular Data Registry (NCDR) Cath-PCI Registry AKI risk model will be used to estimated the predicted risk of CI-AKI, and safe contrast limits will be estimated using the ePRISM, Acute Kidney Injury Model with Contrast Sensitivities and Dialysis Risk (Health Outcomes Sciences) software, incorporated within the Alberta Provincial Project for Outcomes Assessment in Coronary Heart Disease (APPROACH) Cardiac Catheterization software.

Study Design: Using a stepped-wedge design, clusters of cardiologists who perform diagnostic or therapeutic cardiac catheterization in each centre will be randomized to be introduced to the intervention at sequential time points spaced over 20 months. At each step, cardiologists who have not yet been randomized will serve as controls.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-01-22
• Study First Submitted: 2018-02-27
• Study First Submitted QC: 2018-02-27
• Study First Posted: 2018-03-05
• Primary Completion: 2019-11-01
• Study Completion: 2020-11-01
• Status Verified: 2021-05
• Last Update Submitted: 2023-11-27
• Last Update Posted: 2023-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7280

Inclusion Criteria

• Adult patients undergoing diagnostic coronary angiography or coronary intervention in Alberta

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Exclusion Criteria

• Emergency primary percutaneous coronary intervention for ST-elevation myocardial infarction
• Receiving dialysis at time of cardiac catheterization procedure
• Non-Alberta resident

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Control	Control	Usual care.
Intervention	Intervention	Cardiologists will receive computerized clinical decision support information for CI-AKI prevention for patients identified above the median (\> 5%) risk of AKI based on the NCDR risk prediction model for CI-AKI.

Primary Outcome Measures

Name	Time	Method
Acute Kidney Injury	Within 4 days after procedure	\>26 micromol/L or 50% increase in serum creatinine

Secondary Outcome Measures

Name	Time	Method
Post-Procedural Hospital Bed Days	Thirty days after procedure	Number of days in hospital including length of stay plus readmissions up to 30 days after procedure
Change in eGFR	One year after procedure	Change in eGFR at one year fro pre-procedural baseline (estimated using CKD-EPI equation)
Kidney Events	On year after procedure	Hospital admission for acute kidney injury or dialysis
Death	One year after procedure	Total mortality
Cardiac Events	One year after procedure	Hospital admission for angina, myocardial infarction, heart failure, or unplanned revascularization procedure (excluding staged procedures)
Cardiovascular-specific quality of life	One year after procedure	Seattle Angina Questionnaire
Intravenous Fluid	Day of procedure	Volume of intravenous fluids used for each case
End-stage Kidney Disease	One year after procedure	Kidney failure requiring dialysis, kidney transplantation, or conservative management of kidney failure with eGFR\<15 mL/min/1.73m2
Generic Quality of Life	One year after procedure	EQ-5D
Contrast Volume	Day of procedure	Volume of contrast used for each case

Trial Locations

Locations (3)

Foothills Medical Centre; 🇨🇦 Calgary, Alberta, Canada

Royal Alexandra Hospital; 🇨🇦 Edmonton, Alberta, Canada

University of Alberta Hospital; 🇨🇦 Edmonton, Alberta, Canada