CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 399 enrolled
Drug / intervention
N-Acetylcysteine (NAC) +1 moredrug
Likely dose
N-Acetylcysteine (NAC) 3 gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00780962
NCT00780962Phase 2Completed

N-Acetylcysteine to Prevent Radiocontrast Nephropathy in Emergency Department Patients

Beth Israel Deaconess Medical Center·interventional·Posted Oct 28, 2008·Updated Oct 29, 2024

In Brief

A Phase 2 clinical trial evaluating N-Acetylcysteine (NAC) and 0.9% Sodium-chloride for Radiocontrast Nephropathy. Completed, enrolled 399 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 28, 2008
Enrollment StartOct 16, 2007
Primary CompletionAug 9, 2010
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 17.7 years ago

Interventions

N-Acetylcysteine (NAC)drug

Experimental: * Before CT: 3 g NAC IV in 500 cc of 0.9% Sodium-chloride * After CT: 200 mg NAC/hour in 0.9% Sodium-chloride at 67 cc/hour for up to 24 hours.

0.9% Sodium-chloridedrug

Placebo: * Before CT: 500 cc 0.9% Sodium-chloride * After CT: NS at 67 cc/hour for up to 24 hours.