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

Primary Purpose

Chronic Renal Failure

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
NAC Bicarbonate
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Renal Failure focused on measuring N-acetylcysteine, nephropathy, bicarbonate

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All Sexes

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

Sites / Locations

  • Seoul National University HospitalRecruiting
  • Seoul National University Bundang HospitalRecruiting

Outcomes

Primary Outcome Measures

the rate of CIN

Secondary Outcome Measures

mortality

Full Information

First Posted
July 13, 2007
Last Updated
July 23, 2010
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00501475
Brief Title
NAC in Preventing CIN in CRF Patients Who Need Enhanced CT Scan in ED
Study Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Unknown status
Study Start Date
March 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Renal Failure
Keywords
N-acetylcysteine, nephropathy, bicarbonate

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
NAC Bicarbonate
Primary Outcome Measure Information:
Title
the rate of CIN
Time Frame
3 days after CT scan
Secondary Outcome Measure Information:
Title
mortality
Time Frame
30 days after CT scan

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kyuseok Kim, M.D
Phone
82-31-787-3049
Email
dremkks@snubh.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyuseok Kim, MD
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
State/Province
28 Yongon-dong, Chongro-gudo
ZIP/Postal Code
110-744
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kyuseok Kim, MD
Phone
82-31-787-3049
Email
dremkks@snubh.org
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeongi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joong Eui Rhee, MD
Phone
82-31-787-3049
Email
rheeje@snubh.org
First Name & Middle Initial & Last Name & Degree
Kyuseok Kim, MD

12. IPD Sharing Statement

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

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