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

Recruiting now · Phase 4

Conditions studied: AKI (Acute Kidney Injury) Due to Trauma

In brief

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 facts

Study ID

NCT04279457

Run by

CAMC Health System

People needed

1802

Starts

2020-02-03

Expected to finish

2022-02-03

Last updated by the study team

2020-02-24

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Inclusion criteria:
• 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
• Obtaining a Cardiac catheterization.
• HTN/Diabetes
• Inpatient and outpatient

You may not qualify if…

• Exclusion criteria:
• 91 years of age or older
• Serum creatinine < 1.5mg/dl
• eGFR > 60ml/min
• Pregnancy
• Dialysis
• Dye Allergy

Where it is running

• CAMC Health Education and Research Institute — Charleston, West Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.