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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00501475
Recruitment Status : Unknown
Verified July 2010 by Seoul National University Hospital.
Recruitment status was:  Recruiting
First Posted : July 16, 2007
Last Update Posted : July 27, 2010
Sponsor:
Information provided by:
Seoul National University Hospital

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.

Condition or disease Intervention/treatment Phase
Chronic Renal Failure Drug: NAC Bicarbonate Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Study Start Date : March 2007
Estimated Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Failure




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

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


Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00501475


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

Locations
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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
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Principal Investigator: Kyuseok Kim, MD Seoul National University Bundang Hospital

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ClinicalTrials.gov Identifier: NCT00501475    
Other Study ID Numbers: 06-2006-084
First Posted: July 16, 2007    Key Record Dates
Last Update Posted: July 27, 2010
Last Verified: July 2010
Keywords provided by Seoul National University Hospital:
N-acetylcysteine
nephropathy
bicarbonate
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic