AKI (Acute Kidney Injury) Due to Trauma Clinical Trial
Official 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
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.
Coronary angiography (CAG) for diagnostic or therapeutic purposes such as percutaneous
coronary intervention (PCI) is one of the common procedures associated with Contrast-induced
nephropathy (CIN). The reported incidence of contrast induced nephropathy (CIN) in high-risk
patients following CAG varies from 10% to 30%1. The development of CIN after diagnostic
coronary angiography and/or percutaneous coronary intervention (PCI) is associated with
prolonged hospitalization and a remarkable increase in morbidity, early and late mortality
and costs. 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 CM,
repeated exposure to contrast within 48 h, volume of contrast used, etc.)2-5. 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 lowosmolarity or alternative agents, but one of the most
obvious means is to minimize contrast volume. Patients that have a serum creatinine of >
1.5mg/dl and an eGFR < 60ml/min might be at higher risk for AKIs. In quarter one of 2018,
CAMC's in-hospital risk-adjusted acute kidney injury for patients undergoing PCI was 10.64,
and the US 50th percentile was 6.476. The goal of this study is to reduce in-hospital
risk-adjusted acute kidney injury for patients undergoing PCI, below the US 50th,
percentile-based NCDR quarterly results of the Cath-PCI registry by quarter one of 2020.
CIN is one of the leading causes of acute kidney injury at Charleston Area Medical Center it
is imperative to take steps to prevent it. CIN is associated with a 13% increase in one- year
mortality rate when comparing patients without CIN. Studies have also shown an increase in
inpatient length of stay and substantial increase cost for patients who experienced CIN. The
economic burden associated with CIN is high, the average in-hospital cost of CIN is $10,345
7. Adopting targeted interventions will reduce the incidence of CIN and the overall economic
burden at Charleston Area Medical Center.
This trial is aimed at observing whether the use of the monitoring system Dye-Vert PLUS in
conjugation with implementing a pre-hydration protocol on patients with high risk for CIN
admitted for cardiac angiography and/or interventional cath lab procedures may reduce the
incidence of CIN. An additional aim of the study will be to assess if use of the Dye-Vert
PLUS monitoring system reduces the use of mean contrast media given in high-risk patients.
Additional aims of this initiative will be to evaluate contrast-related complications, such
as hypersensitivity reactions, as well as the associated impact of contrast-related
complications on hospital health 3 care economics. This initiative will strive to incorporate
clinical practice guidelines from SCAI Expert Consensus Statement: 2016 Best Practices in the
Cardiac Catheterization Laboratory related to patient risk screening, pre-procedure
hydration, and minimizing contrast media dose used.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04292262 -
Acute Kidney Injury in Polytrauma Patients in Intensive Care Unit
|