Automated Prediction and Prevention of Contrast Induced Nephropathy After Cardiac Catheterization

NCT ID: NCT03305874

Last Updated: 2023-08-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 5 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-03-07
• Study Completion Date: 2023-07-17

Brief 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.

Detailed 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.

Conditions

Contrast-induced Nephropathy

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: OTHER

Study Groups

Study Group

Prospectively, inpatients undergoing percutaneous coronary intervention (PCI) will be consented, and the computer-based contrast induced nephropathy (CBCIN) risk score will be calculated and displayed to the operator, along with suggested standard CIN-avoidance strategies during the PCI. 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.

Exposure to CBCIN risk score

Intervention Type: OTHER

The computer-based contrast induced nephropathy (CBCIN) risk score and associated standard hydration strategy will be displayed on a monitor in front of the treating interventional cardiologist during the entirety of the PCI case. Since this scoring system and hydration strategy are both available in the peer-reviewed literature, clinical use of these data and implementation of a CIN-avoidance strategy is not experimental; however, the display of these data to interventional cardiologists is experimental. Based on exposure to these data, the treating interventional cardiologist may use the information as clinically appropriate (i.e. it is not the basis for clinical decisions).

Comparator Group

Retrospectively, inpatients who underwent PCI and had at least two consecutive daily serum creatinine measurements will be selected. These patients will then be matched to the prospective patients, and matched by age and gender. Baseline CBCIN score will be calculated and other demographic and outcomes information will be obtained from medical records review.

No interventions assigned to this group

Interventions

Exposure to CBCIN risk score

The computer-based contrast induced nephropathy (CBCIN) risk score and associated standard hydration strategy will be displayed on a monitor in front of the treating interventional cardiologist during the entirety of the PCI case. Since this scoring system and hydration strategy are both available in the peer-reviewed literature, clinical use of these data and implementation of a CIN-avoidance strategy is not experimental; however, the display of these data to interventional cardiologists is experimental. Based on exposure to these data, the treating interventional cardiologist may use the information as clinically appropriate (i.e. it is not the basis for clinical decisions).

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Philips Healthcare

INDUSTRY

Sponsor Role: collaborator

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John E. A. Blair, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

The University of Chicago

Chicago, Illinois, United States

Countries

United States

Other Identifiers

IRB17-1005

Identifier Type: -

Identifier Source: org_study_id