Contrast RISK (Reducing Injury Sustained by Kidneys) (Contrast RISK)
Primary Purpose
Acute Kidney Injury (Nontraumatic), Coronary Artery Disease
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Intervention
Control
Sponsored by
About this trial
This is an interventional prevention trial for Acute Kidney Injury (Nontraumatic) focused on measuring acute kidney injury, heart disease, cardiac catheterization
Eligibility Criteria
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
Sites / Locations
- Foothills Medical Centre
- Royal Alexandra Hospital
- University of Alberta Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Intervention
Control
Arm Description
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.
Usual care.
Outcomes
Primary Outcome Measures
Acute Kidney Injury
>26 micromol/L or 50% increase in serum creatinine
Secondary Outcome Measures
Post-Procedural Hospital Bed Days
Number of days in hospital including length of stay plus readmissions up to 30 days after procedure
Death
Total mortality
Change in eGFR
Change in eGFR at one year fro pre-procedural baseline (estimated using CKD-EPI equation)
Cardiac Events
Hospital admission for angina, myocardial infarction, heart failure, or unplanned revascularization procedure (excluding staged procedures)
Kidney Events
Hospital admission for acute kidney injury or dialysis
End-stage Kidney Disease
Kidney failure requiring dialysis, kidney transplantation, or conservative management of kidney failure with eGFR<15 mL/min/1.73m2
Generic Quality of Life
EQ-5D
Cardiovascular-specific quality of life
Seattle Angina Questionnaire
Contrast Volume
Volume of contrast used for each case
Intravenous Fluid
Volume of intravenous fluids used for each case
Full Information
NCT ID
NCT03453996
First Posted
February 27, 2018
Last Updated
May 3, 2021
Sponsor
University of Calgary
Collaborators
Alberta Innovates Health Solutions, Alberta Health services, University of Alberta
1. Study Identification
Unique Protocol Identification Number
NCT03453996
Brief Title
Contrast RISK (Reducing Injury Sustained by Kidneys)
Acronym
Contrast RISK
Official Title
Evaluating Enhanced Clinical Decision Support for Prevention of Contrast-Induced Acute Kidney Injury in Cardiac Catheterization
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
January 22, 2018 (Actual)
Primary Completion Date
November 1, 2019 (Actual)
Study Completion Date
November 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Calgary
Collaborators
Alberta Innovates Health Solutions, Alberta Health services, University of Alberta
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury (Nontraumatic), Coronary Artery Disease
Keywords
acute kidney injury, heart disease, cardiac catheterization
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
7280 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Other
Arm Description
Usual care.
Intervention Type
Other
Intervention Name(s)
Intervention
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Usual procedural care provided by cardiologist without introduction of the computerized clinical decision support information.
Primary Outcome Measure Information:
Title
Acute Kidney Injury
Description
>26 micromol/L or 50% increase in serum creatinine
Time Frame
Within 4 days after procedure
Secondary Outcome Measure Information:
Title
Post-Procedural Hospital Bed Days
Description
Number of days in hospital including length of stay plus readmissions up to 30 days after procedure
Time Frame
Thirty days after procedure
Title
Death
Description
Total mortality
Time Frame
One year after procedure
Title
Change in eGFR
Description
Change in eGFR at one year fro pre-procedural baseline (estimated using CKD-EPI equation)
Time Frame
One year after procedure
Title
Cardiac Events
Description
Hospital admission for angina, myocardial infarction, heart failure, or unplanned revascularization procedure (excluding staged procedures)
Time Frame
One year after procedure
Title
Kidney Events
Description
Hospital admission for acute kidney injury or dialysis
Time Frame
On year after procedure
Title
End-stage Kidney Disease
Description
Kidney failure requiring dialysis, kidney transplantation, or conservative management of kidney failure with eGFR<15 mL/min/1.73m2
Time Frame
One year after procedure
Title
Generic Quality of Life
Description
EQ-5D
Time Frame
One year after procedure
Title
Cardiovascular-specific quality of life
Description
Seattle Angina Questionnaire
Time Frame
One year after procedure
Title
Contrast Volume
Description
Volume of contrast used for each case
Time Frame
Day of procedure
Title
Intravenous Fluid
Description
Volume of intravenous fluids used for each case
Time Frame
Day of procedure
Other Pre-specified Outcome Measures:
Title
Total direct health care costs
Description
Total direct health care costs
Time Frame
One year after procedure
Title
Cost per quality-adjusted life year
Description
Total direct health care costs per quality adjusted life year
Time Frame
One year after procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew T James, MD PhD
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
Facility Information:
Facility Name
Foothills Medical Centre
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
Royal Alexandra Hospital
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Due to Alberta privacy regulations, unable to share data
Citations:
PubMed Identifier
25516439
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.
Results Reference
background
PubMed Identifier
28678988
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.
Results Reference
background
PubMed Identifier
28545621
Citation
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.
Results Reference
background
PubMed Identifier
36066520
Citation
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.
Results Reference
derived
PubMed Identifier
31472811
Citation
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.
Results Reference
derived
Links:
URL
http://www.h-outcomes.com/
Description
Health Outcomes Sciences
URL
http://www.approach.org/
Description
Alberta Provincial Project for Outcomes Assessment in Coronary Heart Disease
Learn more about this trial
Contrast RISK (Reducing Injury Sustained by Kidneys)
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