Single-Center Prospective Study to Investigate the Difference in the Incidence of Contrast-Induced Nephropathy in High-Risk Patients With the Use of the Dye-Vert Plus System
Single-Center Prospective Study to Investigate the Difference in the Incidence of Contrast-Induced Nephropathy in High-Risk Patients With the Use of the Dye-Vert Plus System
Coronary angiography (CAG) for diagnostic or therapeutic purposes such as percutaneous
 coronary intervention (PCI) is one of the common procedures which require the use of
 intravenous contrast media. The reported incidence of contrast induced nephropathy (CIN) in
 high-risk patients following CAG varies from 10% to 30%. The high rate of CIN in post-PCI
 patients could be related either to the patient (advanced age, previous CKD, diabetes,
 dehydration, and concomitant use of other nephrotoxic drugs) or procedure related
 (intra-arterial route of administration, use of high osmolar contrast media, repeated
 exposure to contrast within 48 hours, volume of contrast used). Several strategies to prevent
 or treat CIN have been developed, including hydration, N-acetyl-cysteine, statins, ascorbic
 acid, bicarbonate, aminophylline, forced diuresis, renal replacement therapy, and choice of
 low-osmolarity or alternative agents, but one of the most obvious means is to minimize
 contrast volume. The DyeVert plus Contrast Reduction System, is designed to lower the amount
 of contrast dye the kidneys are exposed to during a procedure. Because the amount of contrast
 dye is precisely controlled. The purpose of this prospective study is to understand how the
 monitoring system of Dye-Vert Plus will impact Acute Kidney Injuries rates in high-risk
 patients undergoing cardiac catheterization when used in conjunction with a standardized
 hydration policy.
Coronary angiography (CAG) for diagnostic or therapeutic purposes such as percutaneous
 coronary intervention (PCI) is one of the common procedures associated with Contrast-induced
 nephropathy (CIN). The reported incidence of contrast induced nephropathy (CIN) in high-risk
 patients following CAG varies from 10% to 30%1. The development of CIN after diagnostic
 coronary angiography and/or percutaneous coronary intervention (PCI) is associated with
 prolonged hospitalization and a remarkable increase in morbidity, early and late mortality
 and costs. The high rate of CIN in post-PCI patients could be related either to the patient
 (advanced age, previous CKD, diabetes, dehydration, and concomitant use of other nephrotoxic
 drugs) or procedure related (intra-arterial route of administration, use of high osmolar CM,
 repeated exposure to contrast within 48 h, volume of contrast used, etc.)2-5. Several
 strategies to prevent or treat CIN have been developed, including hydration,
 N-acetyl-cysteine, statins, ascorbic acid, bicarbonate, aminophylline, forced diuresis, renal
 replacement therapy, and choice of lowosmolarity or alternative agents, but one of the most
 obvious means is to minimize contrast volume. Patients that have a serum creatinine of >
 1.5mg/dl and an eGFR < 60ml/min might be at higher risk for AKIs. In quarter one of 2018,
 CAMC's in-hospital risk-adjusted acute kidney injury for patients undergoing PCI was 10.64,
 and the US 50th percentile was 6.476. The goal of this study is to reduce in-hospital
 risk-adjusted acute kidney injury for patients undergoing PCI, below the US 50th,
 percentile-based NCDR quarterly results of the Cath-PCI registry by quarter one of 2020.

 CIN is one of the leading causes of acute kidney injury at Charleston Area Medical Center it
 is imperative to take steps to prevent it. CIN is associated with a 13% increase in one- year
 mortality rate when comparing patients without CIN. Studies have also shown an increase in
 inpatient length of stay and substantial increase cost for patients who experienced CIN. The
 economic burden associated with CIN is high, the average in-hospital cost of CIN is $10,345
 7. Adopting targeted interventions will reduce the incidence of CIN and the overall economic
 burden at Charleston Area Medical Center.

 This trial is aimed at observing whether the use of the monitoring system Dye-Vert PLUS in
 conjugation with implementing a pre-hydration protocol on patients with high risk for CIN
 admitted for cardiac angiography and/or interventional cath lab procedures may reduce the
 incidence of CIN. An additional aim of the study will be to assess if use of the Dye-Vert
 PLUS monitoring system reduces the use of mean contrast media given in high-risk patients.
 Additional aims of this initiative will be to evaluate contrast-related complications, such
 as hypersensitivity reactions, as well as the associated impact of contrast-related
 complications on hospital health 3 care economics. This initiative will strive to incorporate
 clinical practice guidelines from SCAI Expert Consensus Statement: 2016 Best Practices in the
 Cardiac Catheterization Laboratory related to patient risk screening, pre-procedure
 hydration, and minimizing contrast media dose used.
Inclusion Criteria:

 -  Inclusion criteria:

 1. 18 years of age or older

 2. Scheduled to undergo CAG and/or PCI

 3. Baseline estimated glomerular filtration rate (eGFR) of ≥20 and ≤60 mL/ min/1.73
 m2

 4. Serum creatinine > 1.5mg/dl

 5. Obtaining a Cardiac catheterization.

 6. HTN/Diabetes

 7. Inpatient and outpatient

 Exclusion Criteria:

 -  Exclusion criteria:

 1. 91 years of age or older

 2. Serum creatinine < 1.5mg/dl

 3. eGFR > 60ml/min

 4. Pregnancy

 5. Dialysis

 6. Dye Allergy