Dye-Vert Plus System for Preventing Kidney Injury During Heart Procedures

This study is looking at whether a device called the DyeVert Plus System can help prevent acute kidney injury (AKI) in people at high risk who are having heart procedures like coronary angiography (CAG) or percutaneous coronary intervention (PCI). These procedures sometimes use a special dye that can affect the kidneys. The DyeVert Plus System helps doctors monitor and limit the amount of dye used. Participants will also receive a standardized hydration protocol, similar to the Poseidon protocol. Researchers will check for AKI at 3 days to see if the DyeVert Plus System makes a difference. You may be able to join if you are 18 or older, are scheduled for CAG or PCI, have certain kidney function levels (eGFR between 20 and 60 mL/min/1.73 m2, and serum creatinine over 1.5 mg/dl), and have high blood pressure or diabetes. The current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 1802 participants. It is a single-center prospective study, meaning all participants are at one location and followed forward in time.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for acute kidney injury (AKI) at 3 days after the procedure.

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NCT04279457

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
PHASE4Ages 18–90InterventionalHealth services
CAMC Health System
~1,802 participants
Updated 2020-02-24 on ClinicalTrials.gov
What's tested:DyeVert Plus SystemStandardized hydration protocol

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Monitoring of AKI
Measured over 3 days
AKI (Acute Kidney Injury) Due to Trauma
1 sites across 1 states
West Virginia1

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  • Monitoring of AKI3 days

    Determined by GFR levels