Contrast RISK (Reducing Injury Sustained by Kidneys)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluating Enhanced Clinical Decision Support for Prevention of Contrast-Induced Acute Kidney Injury in Cardiac Catheterization

Conditions
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Acute Kidney Injury (Nontraumatic), Coronary Artery Disease

Intervention / Treatment
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* Other: Intervention
* Other: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients undergoing diagnostic coronary angiography or coronary intervention in Alberta Exclusion Criteria: Emergency primary percutaneous coronary intervention for ST-elevation myocardial infarction Receiving dialysis at time of cardiac catheterization procedure Non-Alberta resident

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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. | Other: Intervention<br>* Computerized clinical decision support intervention. This intervention consists of 2 decision support components for CI-AKI prevention: Estimation of safe contrast limit to reduce the relative risk of CI-AKI by 20% (ePRISM Acute Kidney Injury Model with Contrast Sensitivities and Dialysis Risk software from Health Outcomes Sciences) Patient weight and left ventricular end diastolic pressure (LVEDP) based intravenous crystalloid fluid recommendation.<br>|
| Other: Control<br>Usual care. | Other: Control<br>* Usual procedural care provided by cardiologist without introduction of the computerized clinical decision support information.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute Kidney Injury | >26 micromol/L or 50% increase in serum creatinine | Within 4 days after procedure | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute kidney injury, heart disease, cardiac catheterization