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

Chronic Renal Failure Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00501475
• Other study ID #: 06-2006-084
• Status: Recruiting
• Phase: Phase 4
• First received: July 13, 2007
• Last updated: July 23, 2010
• Start date: March 2007
• Est. completion date: October 2010

Study information

• Verified date: July 2010
• Source: Seoul National University Hospital
• Contact: Kyuseok Kim, M.D
• Phone: 82-31-787-3049
• Email: dremkks[@]snubh.org
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 0
• Est. completion date: October 2010
• Gender: Both
• Age group: 15 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chronic Renal Failure
• Kidney Failure, Chronic

Intervention

Drug:
• NAC Bicarbonate

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeongi-do
Korea, Republic of	Seoul National University Hospital	Seoul	28 Yongon-dong, Chongro-gudo

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the rate of CIN		3 days after CT scan
Secondary	mortality		30 days after CT scan