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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Seoul National University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT00501475
First received: July 13, 2007
Last updated: July 23, 2010
Last verified: July 2010
  Purpose

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.


Condition Intervention Phase
Chronic Renal Failure
Drug: NAC Bicarbonate
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • the rate of CIN [ Time Frame: 3 days after CT scan ]

Secondary Outcome Measures:
  • mortality [ Time Frame: 30 days after CT scan ]

Study Start Date: March 2007
Estimated Study Completion Date: October 2010
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.

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00501475

Contacts
Contact: Kyuseok Kim, M.D 82-31-787-3049 dremkks@snubh.org

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, 28 Yongon-dong, Chongro-gudo, Korea, Republic of, 110-744
Contact: Kyuseok Kim, MD    82-31-787-3049    dremkks@snubh.org   
Seoul National University Bundang Hospital Recruiting
Seongnam-si, Gyeongi-do, Korea, Republic of, 463-707
Contact: Joong Eui Rhee, MD    82-31-787-3049    rheeje@snubh.org   
Principal Investigator: Kyuseok Kim, MD         
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Kyuseok Kim, MD Seoul National University Bundang Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00501475     History of Changes
Other Study ID Numbers: 06-2006-084
Study First Received: July 13, 2007
Last Updated: July 23, 2010
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:
N-acetylcysteine
nephropathy
bicarbonate

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic

ClinicalTrials.gov processed this record on September 18, 2014