NCT00501475

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2007

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 13, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 16, 2007

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

July 27, 2010

Status Verified

July 1, 2010

First QC Date

July 13, 2007

Last Update Submit

July 23, 2010

Conditions

Chronic Renal Failure

Keywords

N-acetylcysteinenephropathybicarbonate

Outcome Measures

Primary Outcomes (1)

  • the rate of CIN

    3 days after CT scan

Secondary Outcomes (1)

  • mortality

    30 days after CT scan

Interventions

NAC BicarbonateDRUG

Eligibility Criteria

Age15 Years+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • CRF patients who need enhanced CT scan

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Seoul National University Hospital

Seoul, 28 Yongon-dong, Chongro-gudo, 110-744, South Korea

RECRUITING

Seoul National University Bundang Hospital

Seongnam-si, Gyeongi-do, 463-707, South Korea

RECRUITING

MeSH Terms

Conditions

Kidney Failure, ChronicKidney Diseases

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Kyuseok Kim, MD

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kyuseok Kim, M.D

CONTACT

82-31-787-3049dremkks@snubh.org

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 13, 2007

First Posted

July 16, 2007

Study Start

March 1, 2007

Study Completion

October 1, 2010

Last Updated

July 27, 2010

Record last verified: 2010-07

Locations

KR(2)