Automated Prediction and Prevention of Contrast Induced Nephropathy After Cardiac Catheterization

  • STATUS
    Recruiting
  • End date
    Mar 22, 2023
  • participants needed
    390
  • sponsor
    University of Chicago
Updated on 22 January 2021

Summary

Contrast agent is typically used during routine cardiac intervention in order to enhance the imaging necessary to perform the procedure. Using this contrast agent could lead to kidney injury, called contrast induced nephropathy (CIN). Currently, the methods used to reduce the risk of CIN include reducing the amount of contrast agent used and using a hydration strategy during procedure. A computer-based risk tool has been developed which reports a risk score for the likelihood a person undergoing cardiac intervention gets CIN and a proposed corresponding hydration strategy to reduce the risk of CIN. The purpose of this study is to determine whether the rate of CIN decreases when the treating physician has access to this risk tool during the procedure.

Description

This is a case-control series comparing a strategy using a computer-based contrast induced nephropathy (CBCIN) risk tool in patients undergoing PCI versus usual care. Only inpatients will be included in this study. These inpatients will be compared to historical controls obtained using the medical record of age- and gender-matched inpatients who underwent cardiac catheterization with at least two consecutive daily post-procedure creatinine values. The percentage PCI will be matched in the retrospective series.

In the prospective group, the operator will be exposed to the CBCIN risk tool before and during care delivery with estimated CIN risk. The CBCIN risk tool estimates CIN risk based on the status of known risk factors (and suggests an associated standard hydration strategy based on left-ventricular end-diastolic pressure), which are automatically prepared from the patient's Electronic Medical Record and presented to the operator for review. This functionality has been evaluated in previous research and was found to be stable and reliable. Based on the data presented by and reviewed in the CBCIN risk tool, the operator may use the information and adjust therapy as clinically indicated (i.e. the risk tool is not the basis for clinical decisions). Following the PCI, serum creatinine will be measured as per treating physician, but those who undergo at least two consecutive daily serum creatinine measurements starting the day after the procedure will be included in the study. These patients will be called 6 months and 12 months post-procedure to determine mortality and re-hospitalization status.

Details
Condition Contrast Induced Nephropathy
Treatment Exposure to CBCIN risk score
Clinical Study IdentifierNCT03305874
SponsorUniversity of Chicago
Last Modified on22 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Inpatients age 21 years seen at the University of Chicago Medical Center with
a clinical indication for cardiac catheterization with high likelihood of PCI
or those undergoing planned PCI will be screened for enrollment into our
study. Following PCI, these patients must have at least two consecutive daily
creatinine measurements starting the day after the PCI, but clinically-
indicated according to the inpatient treating physician

Exclusion Criteria

Patients being discharged the day after the PCI
Patients who are screened but do not receive PCI
Patients who do not have at least two consecutive daily creatinine measurements starting the day after the PCI
Patients undergoing emergency primary percutaneous coronary intervention for ST-segment elevation myocardial infarction
Patients in cardiogenic shock
Patients with end-stage renal disease or who are on renal replacement therapy
Patients requiring planned mechanical circulatory support for the PCI
Pregnant women (standard PCI screening)
Vulnerable populations such as children, college students, prisoners, non-English speakers, and those with diminished decision-making capacity
Inability or refusal to consent for the study
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