Automated Prediction and Prevention of Contrast Induced Nephropathy After Cardiac Catheterization

Contrast-induced Nephropathy Clinical Trial

Official title:

Automated Prediction and Prevention of Contrast Induced Nephropathy After Cardiac Catheterization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03305874
• Other study ID #: IRB17-1005
• Status: Completed
• Start date: March 7, 2018
• Est. completion date: July 17, 2023

Study information

• Verified date: August 2023
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: July 17, 2023
• Est. primary completion date: July 17, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Contrast-induced Nephropathy
• Kidney Diseases

Intervention

Other:
• 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).

Locations

Country	Name	City	State
United States	The University of Chicago	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Chicago	Philips Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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