Recruiting

Dye-Vert Plus

Sponsor:

CAMC Health System

Code:

NCT04279457

Conditions

AKI (Acute Kidney Injury) Due to Trauma

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

DyeVert Plus System

Standardized hydration protocol

Study Details

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

Study ID

NCT04279457

Start date

Feb 3, 2020

Status verified date

Feb, 2020

Completion date

Feb 3, 2022

Anticipated

Primary completion date

Jan 1, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Inclusion criteria:

1. 18 years of age or older
2. Scheduled to undergo CAG and/or PCI
3. Baseline estimated glomerular filtration rate (eGFR) of ≥20 and ≤60 mL/ min/1.73 m2
4. Serum creatinine > 1.5mg/dl
5. Obtaining a Cardiac catheterization.
6. HTN/Diabetes
7. Inpatient and outpatient

Exclusion Criteria:

  • Exclusion criteria:

1. 91 years of age or older
2. Serum creatinine < 1.5mg/dl
3. eGFR > 60ml/min
4. Pregnancy
5. Dialysis
6. Dye Allergy

Study Design

Enrollment

1802 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

active comparator: Standardized Hydration protocol

These cases will follow Charleston Area Medical Centers standard Hydration protocol

active comparator: Hydration + Device

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

Interventions

DyeVert Plus System

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

Standardized hydration protocol

hydration protocol based up on the Poseidon protocol

Primary outcome measure

  • Monitoring of AKI [ Time Frame: 3 days ]

Central Contacts and Locations

Central contacts

Locations

CAMC Health Education and Research Institute

Recruiting

Charleston, West Virginia, United States, 25304

More Information

Sponsor

CAMC Health System

Last update posted

Feb 24, 2020

Last verified

Feb, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by CAMC Health System on 2020-02-24.