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

Conditions

• AKI (Acute Kidney Injury) Due to Trauma

Eligibility Criteria

Sex

ALL

Age

18 Years - 90 Years

Healthy Volunteers

Not accepted

Interventions

• 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
  hydration protocol based up on the Poseidon protocol

Study Details

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.

Key Dates

Start date

Feb 3, 2020

Status verified

Feb 2020

Primary completion

Jan 1, 2022

Completion

Feb 3, 2022

Study Design

Enrollment

1,802 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Arms

• Active Comparator: Standardized Hydration protocol
  These cases will follow Charleston Area Medical Centers standard Hydration protocol
• Active Comparator: Hydration + Device
  These cases will follow Charleston Area Medical Centers standard hydration protocol plus use the DyeVert Plus System

Primary Outcome Measure

Monitoring of AKI [ Time Frame: 3 days ]

Central Contacts

• Frank H Annie, PhD
  304-388-9921
  [email protected]

Locations (1)

Find similar trials in Charleston, WV