NCT03453996

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7,280

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 22, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 27, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 5, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

November 28, 2023

Status Verified

May 1, 2021

Enrollment Period

1.8 years

First QC Date

February 27, 2018

Last Update Submit

November 27, 2023

Conditions

Acute Kidney Injury (Nontraumatic)Coronary Artery Disease

Keywords

acute kidney injuryheart diseasecardiac catheterization

Outcome Measures

Primary Outcomes (1)

  • Acute Kidney Injury

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

    Within 4 days after procedure

Secondary Outcomes (10)

  • Post-Procedural Hospital Bed Days

    Thirty days after procedure

  • Death

    One year after procedure

  • Change in eGFR

    One year after procedure

  • Cardiac Events

    One year after procedure

  • Kidney Events

    On year after procedure

  • +5 more secondary outcomes

Other Outcomes (2)

  • Total direct health care costs

    One year after procedure

  • Cost per quality-adjusted life year

    One year after procedure

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

OTHER

Usual care.

Other: Control

Interventions

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.

Intervention
ControlOTHER

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

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Foothills Medical Centre

Calgary, Alberta, Canada

Location

Royal Alexandra Hospital

Edmonton, Alberta, Canada

Location

University of Alberta Hospital

Edmonton, Alberta, Canada

Location

Related Publications (5)

  • 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.

    PMID: 25516439BACKGROUND

  • 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.

    PMID: 28678988BACKGROUND

  • 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.

    PMID: 28545621BACKGROUND

  • 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.

    PMID: 36066520DERIVED

  • 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.

    PMID: 31472811DERIVED

Related Links

MeSH Terms

Conditions

Acute Kidney InjuryCoronary Artery DiseaseHeart Diseases

Interventions

Methods

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesCoronary DiseaseMyocardial IschemiaCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Matthew T James, MD PhD

    University of Calgary

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2018

First Posted

March 5, 2018

Study Start

January 22, 2018

Primary Completion

November 1, 2019

Study Completion

November 1, 2020

Last Updated

November 28, 2023

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Due to Alberta privacy regulations, unable to share data

Locations

CA(3)