Radiocontrast Nephropathy Clinical Trial
Official title:
N-Acetylcysteine to Prevent Radiocontrast Nephropathy in Emergency Department Patients
Multiple agents have been studied to prevent radiocontrast nephropathy. One of these agents
is N-Acetylcysteine. Previous trials to assess N-Acetylcysteine's efficacy in the prevention
of contrast nephropathy have been promising. However, previous studies have limited
applicability to the Emergency Department (ED) patient population for two reasons:
- 1) Many of the pretreatment strategies employed in these studies take several hours or
even days to perform, which is not feasible in acutely ill ED patients.
- 2) Most of these studies were conducted in patients undergoing cardiac catheterization.
This may be a very different population than patients in the ED undergoing abdominal or
chest computed tomography.
The investigators wish to study the efficacy of N-acetylcysteine as an agent to prevent
radiocontrast nephropathy in ED patients undergoing computerized tomography. The
investigators propose a randomized, double-blind, controlled trial comparing saline hydration
plus N-acetylcysteine versus saline hydration alone. The hypothesis of this study is that
N-acetylcysteine with normal saline will be more effective than saline alone in the
prevention of radiocontrast nephropathy.
Out of the approximately 110 million Emergency Department (ED) visits in the United States
each year approximately 8.8 million people undergo Contrast-Enhanced Computerized Tomography
(CT) studies in United States EDs each year (based on the investigators experience).
Radiocontrast nephropathy is a serious potential consequence associated with significant
morbidity and mortality. Preliminary data suggests that the rate of Radiocontrast Induced
Nephropathy after Emergency Department CT is approximately 5-7%. This figure, coupled with
our estimate of 8.8 million contrast-enhanced CT studies, suggests that there are somewhere
between 440,000 and 616,000 cases of radiocontrast nephropathy in the US each year that are
caused by ED studies.
Multiple agents have been studied to prevent radiocontrast nephropathy. One of these agents
is N-Acetylcysteine. There is inconclusive evidence about the benefit of this intervention.
Some studies have shown that N-Acetylcysteine administered in either a high-dose intravenous
protocol or a low-dose intravenous plus oral protocol may reduce the incidence of
radiocontrast nephropathy in patients undergoing emergent cardiac catheterization, although
other studies have found no benefit.
It is not clear, however, if these studies generalize to the ED patient undergoing emergency
CT. ED patients often have different comorbidities or higher acuity which may limit the
applicability in the ED patient population for two reasons:
- 1) Many of the pretreatment strategies employed in these studies take several hours or
even days to perform, which is not feasible in acutely ill ED patients.
- 2) Most of these studies were conducted in patients undergoing cardiac catheterization.
This may be a very different population than patients in the ED undergoing abdominal or
chest computed tomography.
The investigators wish to study the efficacy of N-acetylcysteine as an agent to prevent
radiocontrast nephropathy in ED patients undergoing computerized tomography. The
investigators propose a randomized, double-blind, controlled trial comparing saline hydration
plus N-acetylcysteine versus saline hydration alone. The hypothesis of this study is that
N-acetylcysteine with normal saline will be more effective than saline alone in the
prevention of radiocontrast nephropathy.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04196244 -
Intravenous Contrast Computed Tomography Versus Native Computed Tomography in Patients With Acute Abdomen and Impaired Renal Function
|
Phase 4 |