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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • DyeVert Plus System

    Device

    The DyeVert Plus System also contains a reusable Contrast Monitoring Wireless Display (CMW) which communicates with the Dye-Vert Plus Disposable to allow real-time monitoring and display of contrast volumes manually injected compared to a predefined, physician-entered contrast usage threshold throughout the procedure. At the end of the procedure, the CMW displays total procedure contrast volume used (mL), % of physician specified limit , total procedure contrast volume saved (mL), and % contrast saved

  • Standardized hydration protocol

    Other intervention

    hydration protocol based up on the Poseidon protocol

Treatment groups

1,802 Participants
are divided into 2 treatment groups
Group A: Standardized Hydration protocolActive comparator 1 intervention
Group B: Hydration + DeviceActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Monitoring of AKI

Determined by GFR levels

Time frame
3 days

Secondary outcomes

Other outcomes

Sponsors and contacts

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