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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-90
SponsorCAMC Health System

About this trial

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.

Eligibility criteria

Qualifiers

18 years of age or older

Scheduled to undergo CAG and/or PCI

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

Serum creatinine > 1.5mg/dl

Disqualifiers

91 years of age or older

Serum creatinine < 1.5mg/dl

eGFR > 60ml/min

Pregnancy

Trial design

Treatments tested in this trial

  • DyeVert Plus System
  • Standardized hydration protocol

Treatment groups

1,802 Participants
are divided into 2 treatment groups

Sponsors and collaborators