Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
7280 participants
INTERVENTIONAL
2018-01-22
2020-11-01
Brief Summary
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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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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.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
PREVENTION
NONE
Study Groups
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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.
Intervention
Computerized clinical decision support intervention. This intervention consists of 2 decision support components for CI-AKI prevention:
1. 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)
2. Patient weight and left ventricular end diastolic pressure (LVEDP) based intravenous crystalloid fluid recommendation.
Control
Usual care.
Control
Usual procedural care provided by cardiologist without introduction of the computerized clinical decision support information.
Interventions
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Intervention
Computerized clinical decision support intervention. This intervention consists of 2 decision support components for CI-AKI prevention:
1. 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)
2. 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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Receiving dialysis at time of cardiac catheterization procedure
* Non-Alberta resident
18 Years
ALL
No
Sponsors
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Alberta Innovates Health Solutions
OTHER
Alberta Health services
OTHER
University of Alberta
OTHER
University of Calgary
OTHER
Responsible Party
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Principal Investigators
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Matthew T James, MD PhD
Role: PRINCIPAL_INVESTIGATOR
University of Calgary
Locations
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Foothills Medical Centre
Calgary, Alberta, Canada
Royal Alexandra Hospital
Edmonton, Alberta, Canada
University of Alberta Hospital
Edmonton, Alberta, Canada
Countries
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References
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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.
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.
Related Links
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Health Outcomes Sciences
Alberta Provincial Project for Outcomes Assessment in Coronary Heart Disease
Other Identifiers
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REB17-0039
Identifier Type: -
Identifier Source: org_study_id