Automated Prediction and Prevention of Contrast Induced Nephropathy After Cardiac Catheterization

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.

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Key information

Conditions

Contrast-induced Nephropathy

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The University of Chicago

Chicago, Illinois, 60637, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Primary outcomes

Development of CIN

Time frame: up to 4 days

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

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Collaborators

Philips Healthcare

Registry information

Important dates

Study start: 2018
Primary completion: 2023
Study completion: 2023
First posted: Oct 10, 2017
Registry last updated: Aug 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed