Automated Prediction and Prevention of Contrast Induced Nephropathy After Cardiac Catheterization

NCT03305874 | Completed

• 1 other identifier: IRB17-1005
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Contrast-induced Nephropathy

Keywords

contrast-induced nephropathy (CIN); percutaneous coronary intervention (PCI); computer-based risk tool

Outcome Measures

Primary Outcomes (1)

• Development of CIN

  increase in serum creatinine of ≥0.3 mg/dL or ≥50% from the value before the procedure to the highest post-procedure value on days 1-4

  up to 4 days

Study Arms (2)

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.

Other: Exposure to CBCIN risk score

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.

Interventions

Exposure to CBCIN risk score 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).

Study Group

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

A prospective patient may be considered for the study if they are referred to the University of Chicago Cardiac Catheterization Laboratory as an inpatient for either a planned PCI or a diagnostic angiogram with high likelihood for PCI. For the retrospective control series, subjects will be selected from the electronic medical record starting from the date of the study protocol submission backwards until January 1, 2010 if they meet inclusion and exclusion criteria.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Chicago: lead
• Philips Healthcare: collaborator

Study Sites (1)

The University of Chicago

Chicago, Illinois, 60637, United States

Location

Study Officials

• John E. A. Blair, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2017
• First Posted: October 10, 2017
• Study Start: March 7, 2018
• Primary Completion: July 17, 2023
• Study Completion: July 17, 2023
• Last Updated: August 24, 2023

Record last verified: 2023-08

Locations

US (1)