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NCT00780962 · ClinicalTrials.gov registry record · Phase 2

N-Acetylcysteine to Prevent Radiocontrast Nephropathy in Emergency Department Patients

A Phase 2 study of Radiocontrast Nephropathy, sponsored by Beth Israel Deaconess Medical Center.

Completed
Registry status
Phase 2
Development phase
399
Enrollment target
1
Study location

NCT00780962: Completed Phase 2 study of Radiocontrast Nephropathy, sponsored by Beth Israel Deaconess Medical Center.

NCT00780962 is a Phase 2 study of Radiocontrast Nephropathy that has completed, run by Beth Israel Deaconess Medical Center. The registered enrollment target is 399 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (200% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00780962, a Phase 2 study of Radiocontrast Nephropathy, has completed, sponsored by Beth Israel Deaconess Medical Center.

COMPLETED
Registry status
Phase 2
Development phase
399 participants
Enrollment target
1
Study location

Study 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.

Primary Outcome

Contrast-induced nephropathy was defined as an increase in serum creatinine level of greater than or equal to 0.5 mg/dL or an increase of 25% above baseline. The primary outcome was measured by the change in serum creatinine level from the pre-radiocontrast baseline to the serum creatinine level measured 48 to 72 hours after radiocontrast administration.

Conditions Studied

Interventions

  • DRUG N-Acetylcysteine (NAC)
  • DRUG 0.9% Sodium-chloride

Study Locations (1)

Massachusetts

  • Beth Israel Deaconess Medical Center - Boston

Trial Details

FieldValue
Enrollment Target 399 participants
Start Date 2007-10-16
Est. Completion 2010-08-09
Phase Phase 2

What the finished NCT00780962 record still lists

NCT00780962 is an interventional study that assigns participants to a tested intervention. The registered 399 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (200% higher).

The record links to 1 condition, with Radiocontrast Nephropathy appearing as the primary indexed condition, and to 2 interventions - of which N-Acetylcysteine (NAC) is the first listed.

NCT00780962 reports a single indexed study location in Massachusetts.

Frequently Asked Questions

What is clinical trial NCT00780962 about?

NCT00780962 is a clinical study titled "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 ...

What is the current status of trial NCT00780962?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 399 participants. The study started on 2007-10-16. Estimated completion is 2010-08-09.

What conditions does trial NCT00780962 study?

This clinical trial studies the following conditions: Radiocontrast Nephropathy.

What interventions are being tested in trial NCT00780962?

The interventions under investigation include: N-Acetylcysteine (NAC) (DRUG), 0.9% Sodium-chloride (DRUG).

Who is sponsoring clinical trial NCT00780962?

This trial is sponsored by Beth Israel Deaconess Medical Center, which has 488 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00780962 being conducted?

This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT00780962's enrollment target sits among peer trials

399 103rd of 2000 higher than 1,898 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00780962, the US trial registry maintained by the National Library of Medicine. NCT00780962 (mid enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.