NAC in Preventing CIN in CRF Patients Who Need Enhanced CT Scan in ED

July 23, 2010 updated by: Seoul National University Hospital
The purpose of this study is to evaluate the effect of NAC or sodium bicarbonate in preventing the aggravation of renal function in chronic renal failure when enhanced computed tomography scan is checked in emergency room.

Study Overview

Status

Unknown

Intervention / Treatment

Detailed Description

CIN is frequent in CRF patients. However most studies about CIN has been focusing on elective PCI patients. There is no study that the NAC nor sodium bicarbonate would help in preventing CIN in CRF patients who need enhanced CT scan in ED.

Our intention was to investigate the effect of NAC or sodium bicarbonate in preventing the aggravation of renal function in chronic renal failure when enhanced computed tomography scan is checked in emergency room.

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • 28 Yongon-dong, Chongro-gudo
      • Seoul, 28 Yongon-dong, Chongro-gudo, Korea, Republic of, 110-744
        • Recruiting
        • Seoul National University Hospital
        • Contact:
    • Gyeongi-do
      • Seongnam-si, Gyeongi-do, Korea, Republic of, 463-707
        • Recruiting
        • Seoul National University Bundang Hospital
        • Contact:
        • Principal Investigator:
          • Kyuseok Kim, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • CRF patients who need enhanced CT scan

Exclusion Criteria:

  • less than 15 years old
  • hypersensitivity to NAC
  • on dialysis
  • no consent from patient or next of kin

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the rate of CIN
Time Frame: 3 days after CT scan
3 days after CT scan

Secondary Outcome Measures

Outcome Measure
Time Frame
mortality
Time Frame: 30 days after CT scan
30 days after CT scan

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Kyuseok Kim, MD, Seoul National University Bundang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Study Completion (Anticipated)

October 1, 2010

Study Registration Dates

First Submitted

July 13, 2007

First Submitted That Met QC Criteria

July 13, 2007

First Posted (Estimate)

July 16, 2007

Study Record Updates

Last Update Posted (Estimate)

July 27, 2010

Last Update Submitted That Met QC Criteria

July 23, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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