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Contrast RISK (Reducing Injury Sustained by Kidneys)

NCT03453996 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7280

Last updated 2023-11-28

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Alberta Innovates Health Solutions

    collaborator OTHER

  • Alberta Health services

    collaborator OTHER

  • University of Alberta

    collaborator OTHER

  • University of Calgary

    lead OTHER

Principal Investigators

  • Matthew T James, MD PhD · University of Calgary

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-22
Primary Completion
2019-11-01
Completion
2020-11-01

Countries

  • Canada

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03453996 on ClinicalTrials.gov