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NCT04279457 · ClinicalTrials.gov registry record · Phase 4
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
A Phase 4 study, sponsored by CAMC Health System.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 1,802
- Enrollment target
NCT04279457 is a Phase 4 study that is actively recruiting participants, run by CAMC Health System. The registered enrollment target is 1,802 participants.
The verdict
NCT04279457, a Phase 4 study, is actively recruiting participants, sponsored by CAMC Health System.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 1,802 participants
- Enrollment target
Study Summary
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.
Interventions
- DEVICE DyeVert Plus System
- OTHER Standardized hydration protocol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,802 participants |
| Start Date | 2020-02-03 |
| Est. Completion | 2022-02-03 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04279457
The ClinicalTrials.gov registry entry for NCT04279457 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 1,802 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is CAMC Health System, which has 28 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which DyeVert Plus System is the first listed.
NCT04279457 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04279457 about?
NCT04279457 is a clinical study titled "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". 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 var...
What is the current status of trial NCT04279457?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 1,802 participants. The study started on 2020-02-03. Estimated completion is 2022-02-03.
What interventions are being tested in trial NCT04279457?
The interventions under investigation include: DyeVert Plus System (DEVICE), Standardized hydration protocol (OTHER).
Who is sponsoring clinical trial NCT04279457?
This trial is sponsored by CAMC Health System, which has 28 total clinical trials registered on ClinicalTrials.gov.
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