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Contrast RISK (Reducing Injury Sustained by Kidneys)

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03453996
Acronym
Contrast RISK
Enrollment
7280
Registered
2018-03-05
Start date
2018-01-22
Completion date
2020-11-01
Last updated
2023-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury (Nontraumatic), Coronary Artery Disease

Keywords

acute kidney injury, heart disease, cardiac catheterization

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.

Interventions

OTHERIntervention

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.

OTHERControl

Usual procedural care provided by cardiologist without introduction of the computerized clinical decision support information.

Sponsors

Alberta Innovates Health Solutions
CollaboratorOTHER
Alberta Health services
CollaboratorOTHER
University of Alberta
CollaboratorOTHER
University of Calgary
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Acute Kidney InjuryWithin 4 days after procedure\>26 micromol/L or 50% increase in serum creatinine

Secondary

MeasureTime frameDescription
Post-Procedural Hospital Bed DaysThirty days after procedureNumber of days in hospital including length of stay plus readmissions up to 30 days after procedure
DeathOne year after procedureTotal mortality
Change in eGFROne year after procedureChange in eGFR at one year fro pre-procedural baseline (estimated using CKD-EPI equation)
Cardiac EventsOne year after procedureHospital admission for angina, myocardial infarction, heart failure, or unplanned revascularization procedure (excluding staged procedures)
Kidney EventsOn year after procedureHospital admission for acute kidney injury or dialysis
Contrast VolumeDay of procedureVolume of contrast used for each case
Intravenous FluidDay of procedureVolume of intravenous fluids used for each case
End-stage Kidney DiseaseOne year after procedureKidney failure requiring dialysis, kidney transplantation, or conservative management of kidney failure with eGFR\<15 mL/min/1.73m2
Generic Quality of LifeOne year after procedureEQ-5D
Cardiovascular-specific quality of lifeOne year after procedureSeattle Angina Questionnaire

Other

MeasureTime frameDescription
Total direct health care costsOne year after procedureTotal direct health care costs
Cost per quality-adjusted life yearOne year after procedureTotal direct health care costs per quality adjusted life year

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026