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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03453996
Recruitment Status : Completed
First Posted : March 5, 2018
Last Update Posted : May 5, 2021
Sponsor:
Collaborators:
Alberta Innovates Health Solutions
Alberta Health services
University of Alberta
Information provided by (Responsible Party):
University of Calgary

Study Description
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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.


Condition or disease Intervention/treatment Phase
Acute Kidney Injury (Nontraumatic) Coronary Artery Disease Other: Intervention Other: Control Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7280 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluating Enhanced Clinical Decision Support for Prevention of Contrast-Induced Acute Kidney Injury in Cardiac Catheterization
Actual Study Start Date : January 22, 2018
Actual Primary Completion Date : November 1, 2019
Actual Study Completion Date : November 1, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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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:

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


Outcome Measures
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Primary Outcome Measures :
  1. Acute Kidney Injury [ Time Frame: Within 4 days after procedure ]
    >26 micromol/L or 50% increase in serum creatinine


Secondary Outcome Measures :
  1. Post-Procedural Hospital Bed Days [ Time Frame: Thirty days after procedure ]
    Number of days in hospital including length of stay plus readmissions up to 30 days after procedure

  2. Death [ Time Frame: One year after procedure ]
    Total mortality

  3. Change in eGFR [ Time Frame: One year after procedure ]
    Change in eGFR at one year fro pre-procedural baseline (estimated using CKD-EPI equation)

  4. Cardiac Events [ Time Frame: One year after procedure ]
    Hospital admission for angina, myocardial infarction, heart failure, or unplanned revascularization procedure (excluding staged procedures)

  5. Kidney Events [ Time Frame: On year after procedure ]
    Hospital admission for acute kidney injury or dialysis

  6. End-stage Kidney Disease [ Time Frame: One year after procedure ]
    Kidney failure requiring dialysis, kidney transplantation, or conservative management of kidney failure with eGFR<15 mL/min/1.73m2

  7. Generic Quality of Life [ Time Frame: One year after procedure ]
    EQ-5D

  8. Cardiovascular-specific quality of life [ Time Frame: One year after procedure ]
    Seattle Angina Questionnaire

  9. Contrast Volume [ Time Frame: Day of procedure ]
    Volume of contrast used for each case

  10. Intravenous Fluid [ Time Frame: Day of procedure ]
    Volume of intravenous fluids used for each case


Other Outcome Measures:
  1. Total direct health care costs [ Time Frame: One year after procedure ]
    Total direct health care costs

  2. Cost per quality-adjusted life year [ Time Frame: One year after procedure ]
    Total direct health care costs per quality adjusted life year


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03453996


Locations
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Canada, Alberta
Foothills Medical Centre
Calgary, Alberta, Canada
Royal Alexandra Hospital
Edmonton, Alberta, Canada
University of Alberta Hospital
Edmonton, Alberta, Canada
Sponsors and Collaborators
University of Calgary
Alberta Innovates Health Solutions
Alberta Health services
University of Alberta
Investigators
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Principal Investigator: Matthew T James, MD PhD University of Calgary
More Information
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Additional Information:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Calgary
ClinicalTrials.gov Identifier: NCT03453996    
Other Study ID Numbers: REB17-0039
First Posted: March 5, 2018    Key Record Dates
Last Update Posted: May 5, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Due to Alberta privacy regulations, unable to share data

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Calgary:
acute kidney injury
heart disease
cardiac catheterization
Additional relevant MeSH terms:
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Acute Kidney Injury
Coronary Artery Disease
Wounds and Injuries
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
 Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Renal Insufficiency
Kidney Diseases
Urologic Diseases