Contrast RISK (Reducing Injury Sustained by Kidneys)

Coronary Artery Disease Clinical Trial

— Contrast RISK  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03453996
• Other study ID #: REB17-0039
• Status: Completed
• Phase: N/A
• Start date: January 22, 2018
• Est. completion date: November 1, 2020

Study information

• Verified date: May 2021
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7280
• Est. completion date: November 1, 2020
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Acute Kidney Injury (Nontraumatic)
• Coronary Artery Disease
• Wounds and Injuries

Intervention

Other:
• Intervention
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.
• Control
Usual procedural care provided by cardiologist without introduction of the computerized clinical decision support information.

Locations

Country	Name	City	State
Canada	Foothills Medical Centre	Calgary	Alberta
Canada	Royal Alexandra Hospital	Edmonton	Alberta
Canada	University of Alberta Hospital	Edmonton	Alberta

Sponsors (4)

Lead Sponsor	Collaborator
University of Calgary	Alberta Health services, Alberta Innovates Health Solutions, University of Alberta

Country where clinical trial is conducted

Canada, 

References & Publications (3)

Allen DW, Ma B, Leung KC, Graham MM, Pannu N, Traboulsi M, Goodhart D, Knudtson ML, James MT. Risk Prediction Models for Contrast-Induced Acute Kidney Injury Accompanying Cardiac Catheterization: Systematic Review and Meta-analysis. Can J Cardiol. 2017 Jun;33(6):724-736. doi: 10.1016/j.cjca.2017.01.018. Epub 2017 Feb 1. — View Citation

Amin AP, Bach RG, Caruso ML, Kennedy KF, Spertus JA. Association of Variation in Contrast Volume With Acute Kidney Injury in Patients Undergoing Percutaneous Coronary Intervention. JAMA Cardiol. 2017 Sep 1;2(9):1007-1012. doi: 10.1001/jamacardio.2017.2156. — View Citation

Tsai TT, Patel UD, Chang TI, Kennedy KF, Masoudi FA, Matheny ME, Kosiborod M, Amin AP, Weintraub WS, Curtis JP, Messenger JC, Rumsfeld JS, Spertus JA. Validated contemporary risk model of acute kidney injury in patients undergoing percutaneous coronary interventions: insights from the National Cardiovascular Data Registry Cath-PCI Registry. J Am Heart Assoc. 2014 Dec;3(6):e001380. doi: 10.1161/JAHA.114.001380. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Total direct health care costs	Total direct health care costs	One year after procedure
Other	Cost per quality-adjusted life year	Total direct health care costs per quality adjusted life year	One year after procedure
Primary	Acute Kidney Injury	>26 micromol/L or 50% increase in serum creatinine	Within 4 days after procedure
Secondary	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
Secondary	Death	Total mortality	One year after procedure
Secondary	Change in eGFR	Change in eGFR at one year fro pre-procedural baseline (estimated using CKD-EPI equation)	One year after procedure
Secondary	Cardiac Events	Hospital admission for angina, myocardial infarction, heart failure, or unplanned revascularization procedure (excluding staged procedures)	One year after procedure
Secondary	Kidney Events	Hospital admission for acute kidney injury or dialysis	On year after procedure
Secondary	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
Secondary	Generic Quality of Life	EQ-5D	One year after procedure
Secondary	Cardiovascular-specific quality of life	Seattle Angina Questionnaire	One year after procedure
Secondary	Contrast Volume	Volume of contrast used for each case	Day of procedure
Secondary	Intravenous Fluid	Volume of intravenous fluids used for each case	Day of procedure

External Links

•   Alberta Provincial Project for Outcomes Assessment in Coronary Heart Disease
•   Health Outcomes Sciences