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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

Tracking Information
First Submitted Date  ICMJE February 27, 2018
First Posted Date  ICMJE March 5, 2018
Last Update Posted Date May 5, 2021
Actual Study Start Date  ICMJE January 22, 2018
Actual Primary Completion Date November 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 12, 2019)
Acute Kidney Injury [ Time Frame: Within 4 days after procedure ]
>26 micromol/L or 50% increase in serum creatinine
Original Primary Outcome Measures  ICMJE
 (submitted: February 27, 2018)
Acute Kidney Injury [ Time Frame: Within 7 days after procedure ]
>26 micromol/L or 50% increase in serum creatinine
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 12, 2019)
  • 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
  • Death [ Time Frame: One year after procedure ]
    Total mortality
  • Change in eGFR [ Time Frame: One year after procedure ]
    Change in eGFR at one year fro pre-procedural baseline (estimated using CKD-EPI equation)
  • Cardiac Events [ Time Frame: One year after procedure ]
    Hospital admission for angina, myocardial infarction, heart failure, or unplanned revascularization procedure (excluding staged procedures)
  • Kidney Events [ Time Frame: On year after procedure ]
    Hospital admission for acute kidney injury or dialysis
  • 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
  • Generic Quality of Life [ Time Frame: One year after procedure ]
    EQ-5D
  • Cardiovascular-specific quality of life [ Time Frame: One year after procedure ]
    Seattle Angina Questionnaire
  • Contrast Volume [ Time Frame: Day of procedure ]
    Volume of contrast used for each case
  • Intravenous Fluid [ Time Frame: Day of procedure ]
    Volume of intravenous fluids used for each case
Original Secondary Outcome Measures  ICMJE
 (submitted: February 27, 2018)
  • 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
  • Death [ Time Frame: One year after procedure ]
    Total mortality
  • All-cause Readmission [ Time Frame: One year after procedure ]
    Hospital Readmission
  • Cardiac Readmission [ Time Frame: One year after procedure ]
    Hospital readmission for angina, myocardial infarction, heart failure, or unplanned revascularization procedure (excluding staged procedures)
  • Kidney Readmission [ Time Frame: On year after procedure ]
    Hospital readmission for acute kidney injury or dialysis
  • 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
  • Generic Quality of Life [ Time Frame: One year after procedure ]
    EQ-5D
  • Cardiovascular-specific quality of life [ Time Frame: One year after procedure ]
    Seattle Angina Questionnaire
  • Safe Contrast Limit [ Time Frame: Day of procedure ]
    Proportion of procedures completed with or below safe contrast limit
  • Intravenous Fluid [ Time Frame: Day of procedure ]
    Proportion of patients who received recommended intravenous fluids, based on weight and LVEDP (patients with active or recent heart failure within the last 2 weeks or for whom LVEDP could not be measured excluded)
Current Other Pre-specified Outcome Measures
 (submitted: March 2, 2018)
  • Total direct health care costs [ Time Frame: One year after procedure ]
    Total direct health care costs
  • Cost per quality-adjusted life year [ Time Frame: One year after procedure ]
    Total direct health care costs per quality adjusted life year
Original Other Pre-specified Outcome Measures
 (submitted: February 27, 2018)
  • Cost [ Time Frame: One year after procedure ]
    Total direct health care costs
  • Cost per quality-adjusted life year [ Time Frame: One year after procedure ]
    Total direct health care costs per quality adjusted life year
 
Descriptive Information
Brief Title  ICMJE Contrast RISK (Reducing Injury Sustained by Kidneys)
Official Title  ICMJE Evaluating Enhanced Clinical Decision Support for Prevention of Contrast-Induced Acute Kidney Injury in 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Acute Kidney Injury (Nontraumatic)
  • Coronary Artery Disease
Intervention  ICMJE
  • 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.
  • Other: Control
    Usual procedural care provided by cardiologist without introduction of the computerized clinical decision support information.
Study Arms  ICMJE
  • 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.
    Intervention: Other: Intervention
  • Control
    Usual care.
    Intervention: Other: Control
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 3, 2021)
7280
Original Estimated Enrollment  ICMJE
 (submitted: February 27, 2018)
1044
Actual Study Completion Date  ICMJE November 1, 2020
Actual Primary Completion Date November 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03453996
Other Study ID Numbers  ICMJE REB17-0039
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Due to Alberta privacy regulations, unable to share data
Current Responsible Party University of Calgary
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Calgary
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Alberta Innovates Health Solutions
  • Alberta Health services
  • University of Alberta
Investigators  ICMJE
Principal Investigator: Matthew T James, MD PhD University of Calgary
PRS Account University of Calgary
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP