NAC in Preventing CIN in CRF Patients Who Need Enhanced C... | NCT00501475

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

NCT00501475

Sponsor

Seoul National University Hospital

Status

Unknown status

Last Update Posted

Jul 27, 2010Estimated

Enrollment

Not provided

Phase

Phase 4

Conditions

Chronic Renal Failure

Interventions

NAC Bicarbonate

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2007

Primary Completion Date

Not provided

Completion Date

Oct 2010Estimated

First Submitted Date

Jul 13, 2007

First Submission Date that Met QC Criteria

Jul 13, 2007

First Posted Date

Jul 16, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 23, 2010

Last Update Posted Date

Jul 27, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
NAC Bicarbonate	Drug

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

Measure	Description	Time Frame
mortality		30 days after CT scan

Eligibility Module

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Kyuseok Kim, M.D	Contact	82-31-787-3049		dremkks@snubh.org

Overall Officials

Name	Affiliation	Role
Kyuseok Kim, MD	Seoul National University Bundang Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital	Recruiting	Seoul	28 Yongon-dong, Chongro-gudo	110-744	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D007676	Kidney Failure, Chronic
D007674	Kidney Diseases

Ancestor Terms

ID	Term
D051436	Renal Insufficiency, Chronic
D051437	Renal Insufficiency
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided