Contrast RISK (Reducing Injury Sustained by Kidneys) (Contrast RISK)

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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Acute Kidney Injury (Nontraumatic)
• Intervention / Treatment: Other: Intervention; Other: Control

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.

• Study Type: Interventional
• Enrollment (Actual): 7280
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada
      • Foothills Medical Centre
    • Edmonton, Alberta, Canada
      • Royal Alexandra Hospital
    • Edmonton, Alberta, Canada
      • University of Alberta Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Other: Control; Usual care.	Other: Control; Usual procedural care provided by cardiologist without introduction of the computerized clinical decision support information.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total direct health care costs	Total direct health care costs	One year after procedure
Cost per quality-adjusted life year	Total direct health care costs per quality adjusted life year	One year after procedure

Collaborators and Investigators

• Sponsor: University of Calgary
• Collaborators: Alberta Health services; University of Alberta; Alberta Innovates Health Solutions
• Investigators: Principal Investigator: Matthew T James, MD PhD, University of Calgary

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• James MT, Har BJ, Tyrrell BD, Faris PD, Tan Z, Spertus JA, Wilton SB, Ghali WA, Knudtson ML, Sajobi TT, Pannu NI, Klarenbach SW, Graham MM. Effect of Clinical Decision Support With Audit and Feedback on Prevention of Acute Kidney Injury in Patients Undergoing Coronary Angiography: A Randomized Clinical Trial. JAMA. 2022 Sep 6;328(9):839-849. doi: 10.1001/jama.2022.13382. Erratum In: JAMA. 2022 Nov 15;328(19):1981.
• James MT, Har BJ, Tyrrell BD, Ma B, Faris P, Sajobi TT, Allen DW, Spertus JA, Wilton SB, Pannu N, Klarenbach SW, Graham MM. Clinical Decision Support to Reduce Contrast-Induced Kidney Injury During Cardiac Catheterization: Design of a Randomized Stepped-Wedge Trial. Can J Cardiol. 2019 Sep;35(9):1124-1133. doi: 10.1016/j.cjca.2019.06.002. Epub 2019 Jun 7. Erratum In: Can J Cardiol. 2022 Mar;38(3):407.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2018
• Primary Completion (Actual): November 1, 2019
• Study Completion (Actual): November 1, 2020

Study Registration Dates

• First Submitted: February 27, 2018
• First Submitted That Met QC Criteria: February 27, 2018
• First Posted (Actual): March 5, 2018

Study Record Updates

• Last Update Posted (Actual): November 28, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: acute kidney injury; heart disease; cardiac catheterization
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Kidney Diseases; Urologic Diseases; Renal Insufficiency; Coronary Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Coronary Artery Disease; Wounds and Injuries; Acute Kidney Injury
• Other Study ID Numbers: REB17-0039

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Due to Alberta privacy regulations, unable to share data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No