Actively Recruiting
Single-Center Prospective Study to Investigate the Difference in the Incidence of Contrast-Induced Nephropathy in High-Risk Patients Using the Dye-Vert Plus System
Led by CAMC Health System · Updated on 2020-02-24
1802
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the risk of contrast-induced nephropathy (CIN), a type of acute kidney injury, in high-risk patients undergoing coronary angiography (CAG) or percutaneous coronary intervention (PCI). CIN occurs in 10% to 30% of these patients and is linked to factors such as advanced age, kidney disease, diabetes, dehydration, and the use of certain drugs. This study aims to evaluate how using the DyeVert Plus Contrast Reduction System along with a standard hydration protocol may impact the rates of acute kidney injury in these patients. The study compares two groups: one receiving the standard hydration protocol alone and the other receiving the standard hydration plus the DyeVert Plus System. The DyeVert Plus System monitors and reduces the amount of contrast dye used during the procedure by displaying real-time contrast volumes and savings. This device is designed to minimize kidney exposure to contrast media during cardiac catheterization procedures. Participants will be monitored for acute kidney injury over three days following their procedure. Researchers will assess kidney function using measurements such as estimated glomerular filtration rate (eGFR) and serum creatinine. The study also evaluates contrast-related complications and the impact on hospital costs. This prospective trial involves both inpatient and outpatient adults aged 18 to 90 years with specific kidney function criteria, and participation duration includes pre-procedure hydration and post-procedure monitoring.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Scheduled to undergo coronary angiography (CAG) and/or percutaneous coronary intervention (PCI)
- Baseline estimated glomerular filtration rate (eGFR) between 20 and 60 mL/min/1.73 m2
- Serum creatinine greater than 1.5 mg/dl
- Undergoing cardiac catheterization
- Have hypertension or diabetes
- Eligible as inpatient or outpatient
You will not qualify if you...
- 91 years of age or older
- Serum creatinine less than 1.5 mg/dl
- eGFR greater than 60 mL/min
- Pregnant
- On dialysis
- Allergy to contrast dye
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of procedure
Participants will undergo coronary angiography and/or percutaneous coronary intervention while following a standardized hydration protocol. Some participants will also have the DyeVert Plus System used during their procedure to monitor and minimize contrast media volume.
1 procedure visit (in-person)
Duration - 3 days
Participants will be monitored for acute kidney injury and contrast-related complications following the procedure.
Daily visits or assessments for up to 3 days post-procedure
Trial Site Locations
Total: 1 location
1
CAMC Health Education and Research Institute
Charleston, West Virginia, United States, 25304
Actively Recruiting
Research Team
F
Frank H Annie, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here