Automated Prediction and Prevention of Contrast Induced Nephropathy After Cardiac Catheterization
| Status: | Recruiting |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease, Nephrology |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 4/17/2018 |
| Start Date: | March 7, 2018 |
| End Date: | March 2023 |
| Contact: | Margaret Lee, MPH |
| Email: | mlee3@medicine.bsd.uchicago.edu |
| Phone: | 773-702-0347 |
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.
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.
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.
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.
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.
We found this trial at
1
site
5801 South Ellis Avenue
Chicago, Illinois 60637
Chicago, Illinois 60637
773.702.1234
Phone: 773-702-0347
University of Chicago One of the world's premier academic and research institutions, the University of...
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