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Automated Prediction and Prevention of Contrast Induced Nephropathy After Cardiac Catheterization

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03305874
Recruitment Status : Recruiting
First Posted : October 10, 2017
Last Update Posted : March 15, 2018
Sponsor:
Collaborator:
Philips Healthcare
Information provided by (Responsible Party):
University of Chicago

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.

Condition or disease Intervention/treatment
Contrast-induced Nephropathy Other: Exposure to CBCIN risk score

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.

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Study Type : Observational
Estimated Enrollment : 390 participants
Observational Model: Case-Control
Time Perspective: Other
Official Title: Automated Prediction and Prevention of Contrast Induced Nephropathy After Cardiac Catheterization
Actual Study Start Date : March 7, 2018
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Group/Cohort Intervention/treatment
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
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).

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.



Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03305874


Contacts
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Contact: Margaret Lee, MPH 773-702-0347 mlee3@medicine.bsd.uchicago.edu

Locations
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United States, Illinois
The University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Margaret Lee, MPH    773-702-0347    mlee3@medicine.bsd.uchicago.edu   
Contact: John E. A. Blair, MD    773-702-1719    jblair2@medicine.bsd.uchicago.edu   
Sponsors and Collaborators
University of Chicago
Philips Healthcare
Investigators
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Principal Investigator: John E. A. Blair, MD University of Chicago
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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT03305874    
Other Study ID Numbers: IRB17-1005
First Posted: October 10, 2017    Key Record Dates
Last Update Posted: March 15, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University of Chicago:
contrast-induced nephropathy (CIN)
percutaneous coronary intervention (PCI)
computer-based risk tool
Additional relevant MeSH terms:
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Kidney Diseases
Urologic Diseases