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

• ClinicalTrials.gov Identifier: NCT03453996
• Recruitment Status: Completed
• First Posted: March 5, 2018
• Last Update Posted: May 5, 2021
• Sponsor: University of Calgary
• Collaborators: Alberta Innovates Health Solutions; Alberta Health services; University of Alberta
• Information provided by (Responsible Party): University of Calgary

Tracking Information

• First Submitted Date: February 27, 2018
• First Posted Date: March 5, 2018
• Last Update Posted Date: May 5, 2021
• Actual Study Start Date: January 22, 2018
• Actual Primary Completion Date: November 1, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (submitted: February 27, 2018)

Acute Kidney Injury [ Time Frame: Within 7 days after procedure ]

>26 micromol/L or 50% increase in serum creatinine

Current Secondary Outcome Measures (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 (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: Contrast RISK (Reducing Injury Sustained by Kidneys)
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Sequential Assignment; Masking: None (Open Label); Primary Purpose: Prevention

Condition

• Acute Kidney Injury (Nontraumatic)
• Coronary Artery Disease

Intervention

• 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

• 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 *

• 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. Erratum In: JAMA. 2022 Nov 15;328(19):1981.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 3, 2021): 7280
• Original Estimated Enrollment (submitted: February 27, 2018): 1044
• Actual Study Completion Date: November 1, 2020
• Actual Primary Completion Date: November 1, 2019 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT03453996
• Other Study ID Numbers: 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

• 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: University of Calgary
• Original Study Sponsor: Same as current

Collaborators

• Alberta Innovates Health Solutions
• Alberta Health services
• University of Alberta

Investigators

• Principal Investigator: Matthew T James, MD PhD; University of Calgary

• PRS Account: University of Calgary
• Verification Date: May 2021