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

NCT04279457 | Unknown Phase 4 DMC FDA Device

• 1 other identifier: 19-637
• Study Type: interventional
• Target: 1,802
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

AKI (Acute Kidney Injury) Due to Trauma

Outcome Measures

Primary Outcomes (1)

• Monitoring of AKI

  Determined by GFR levels

  3 days

Study Arms (2)

Standardized Hydration protocol

ACTIVE COMPARATOR

These cases will follow Charleston Area Medical Centers standard Hydration protocol

Other: Standardized hydration protocol

Hydration + Device

ACTIVE COMPARATOR

These cases will follow Charleston Area Medical Centers standard hydration protocol plus use the DyeVert Plus System

Device: DyeVert Plus System

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

Hydration + Device

Standardized hydration protocol OTHER

hydration protocol based up on the Poseidon protocol

Standardized Hydration protocol

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

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

Sponsors & Collaborators

• CAMC Health System: lead

Study Sites (1)

CAMC Health Education and Research Institute

Charleston, West Virginia, 25304, United States

RECRUITING

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Central Study Contacts

Frank H Annie, PhD

CONTACT

304-388-9921; frank.h.annie@camc.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The investigators will randomize into each arm
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Design: This is a prospective randomized controlled trial.

Study Record Dates

• First Submitted: February 19, 2020
• First Posted: February 21, 2020
• Study Start: February 3, 2020
• Primary Completion: January 1, 2022
• Study Completion: February 3, 2022
• Last Updated: February 24, 2020

Record last verified: 2020-02

Locations

US (1)