Clinical trial NCT03305874: Automated Prediction and Prevention of Contrast Induced Nephropathy After Cardiac Catheterization
Official title: Automated Prediction and Prevention of Contrast Induced Nephropathy After Cardiac Catheterization
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Contrast-induced Nephropathy
Keywords: contrast-induced nephropathy (CIN)
percutaneous coronary intervention (PCI)
computer-based risk tool
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: Philips Healthcare
First posted: 2017-10-10
Enrollment: 5
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER
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.

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.

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.

Primary outcomes:
measure: Development of CIN
timeFrame: up to 4 days
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: John E. A. Blair, MD
role: PRINCIPAL_INVESTIGATOR
References: