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Acute Kidney Injury (Nontraumatic)Contrast RISKNCT03453996

Contrast RISK (Reducing Injury Sustained by Kidneys)

A study testing Intervention in people with Acute Kidney Injury (Nontraumatic) and Coronary Artery Disease, run by University of Calgary at 3 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Intervention
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7,280 participants
Where
3 sitesCanada
Study dates
22 Jan 2018to 1 Nov 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult patients undergoing diagnostic coronary angiography or coronary intervention in Alberta

Who cannot join

  • Emergency primary percutaneous coronary intervention for ST-elevation myocardial infarction
  • Receiving dialysis at time of cardiac catheterization procedure
  • Non-Alberta resident

Trial locations and contacts

3 sites in 1 country.

Canada3 sites

  • Foothills Medical Centre

    Calgary, Alberta

  • Royal Alexandra Hospital

    Edmonton, Alberta

  • University of Alberta Hospital

    Edmonton, Alberta

Other trials in Canada

About this study

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

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.

Read the 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.

Being tested
Intervention, Control
Keywords
acute kidney injury, heart disease, cardiac catheterization
Medical subject headings
Acute Kidney Injury, Coronary Artery Disease, Heart Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • InterventionOther

    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.

  • ControlOther

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

Study groups in NCT03453996
Study groupRoleWhat they receive
InterventionExperimentalCardiologists 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.
Receives: Other: Intervention
ControlOtherUsual care.
Receives: Other: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Acute Kidney Injury

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

    Measured: Within 4 days after procedure

Secondary outcomes (10)

  1. Post-Procedural Hospital Bed Days

    Number of days in hospital including length of stay plus readmissions up to 30 days after procedure

    Measured: Thirty days after procedure

  2. Death

    Total mortality

    Measured: One year after procedure

  3. Change in eGFR

    Change in eGFR at one year fro pre-procedural baseline (estimated using CKD-EPI equation)

    Measured: One year after procedure

  4. Cardiac Events

    Hospital admission for angina, myocardial infarction, heart failure, or unplanned revascularization procedure (excluding staged procedures)

    Measured: One year after procedure

  5. Kidney Events

    Hospital admission for acute kidney injury or dialysis

    Measured: On year after procedure

  6. End-stage Kidney Disease

    Kidney failure requiring dialysis, kidney transplantation, or conservative management of kidney failure with eGFR<15 mL/min/1.73m2

    Measured: One year after procedure

  7. Generic Quality of Life

    EQ-5D

    Measured: One year after procedure

  8. Cardiovascular-specific quality of life

    Seattle Angina Questionnaire

    Measured: One year after procedure

  9. Contrast Volume

    Volume of contrast used for each case

    Measured: Day of procedure

  10. Intravenous Fluid

    Volume of intravenous fluids used for each case

    Measured: Day of procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2018
  2. Study start22 Jan 2018
  3. Primary completion1 Nov 2019
  4. Study completion1 Nov 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
7,280 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03453996
Sponsor's protocol ID
REB17-0039
Acronym
Contrast RISK
Status last verified
May 2021
First submitted
27 Feb 2018
Last updated
28 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Due to Alberta privacy regulations, unable to share data

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.

    PubMed 25516439

  • 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.

    PubMed 28678988

  • 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.

    PubMed 28545621

  • 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.

    PubMed 36066520

  • 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.

    PubMed 31472811

Questions about this trial

What is this clinical trial studying?

A study testing Intervention in people with Acute Kidney Injury (Nontraumatic) and Coronary Artery Disease, run by University of Calgary at 3 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acute Kidney Injury (time frame: Within 4 days after procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03453996, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023.

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