NASPI: N-Acetylcysteine vs. Ascorbic Acid for Prevention of Contrast Induced Nephropathy in Renal Insufficiency Undergoing Coronary Catheterization
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| First Received Date ICMJE | July 26, 2006 | ||||||||||||||||
| Last Updated Date | November 24, 2006 | ||||||||||||||||
| Start Date ICMJE | February 2005 | ||||||||||||||||
| Primary Completion Date | Not Provided | ||||||||||||||||
| Current Primary Outcome Measures ICMJE |
The mean peak increase of serum creatinine concentration during day1 and day2. | ||||||||||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||
| Change History | Complete list of historical versions of study NCT00356954 on ClinicalTrials.gov Archive Site | ||||||||||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||
| Descriptive Information | |||||||||||||||||
| Brief Title ICMJE | NASPI: N-Acetylcysteine vs. Ascorbic Acid for Prevention of Contrast Induced Nephropathy in Renal Insufficiency Undergoing Coronary Catheterization | ||||||||||||||||
| Official Title ICMJE | N-Acetylcysteine vs. Ascorbic Acid for Prevention of Contrast Induced Nephropathy in Renal Insufficiency Undergoing Coronary Catheterization: NASPI Study-A Randomized Controlled Trial | ||||||||||||||||
| Brief Summary | The contrast induced nephropathy (CIN) has been known to be associated with significant clinical and economic consequences. Many studies were performed to find the pathophysiology and preventive measures for CIN. But the results were somewhat frustrating. Recently, it has been reported that the N-acetylcysteine and ascorbic acid might have preventive effects for CIN by their antioxidant effects.There have been no study to compare these two antioxidant. |
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| Detailed Description | N-acetylcysteine and ascorbic acid may prevent the CIN in the patients with underlying renal insufficiency who is undergoing the coronary angiography. The effect may derive from the antioxidant function of these two antioxidant. We studied to find which of the two antioxidants is more beneficial in prevention of CIN |
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| Study Type ICMJE | Interventional | ||||||||||||||||
| Study Phase | Phase 4 | ||||||||||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention |
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| Condition ICMJE | Kidney Failure | ||||||||||||||||
| Intervention ICMJE |
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| Study Arm (s) | Not Provided | ||||||||||||||||
| Publications * | Not Provided | ||||||||||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||||||
| Recruitment Status ICMJE | Completed | ||||||||||||||||
| Enrollment ICMJE | 250 | ||||||||||||||||
| Completion Date | April 2006 | ||||||||||||||||
| Primary Completion Date | Not Provided | ||||||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||||||||||
| Ages | 19 Years and older | ||||||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||
| Location Countries ICMJE | Korea, Republic of | ||||||||||||||||
| Administrative Information | |||||||||||||||||
| NCT Number ICMJE | NCT00356954 | ||||||||||||||||
| Other Study ID Numbers ICMJE | H-0509-517-158-2 | ||||||||||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||||||||||
| Responsible Party | Not Provided | ||||||||||||||||
| Study Sponsor ICMJE | Seoul National University Hospital | ||||||||||||||||
| Collaborators ICMJE | Not Provided | ||||||||||||||||
| Investigators ICMJE |
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| Information Provided By | Seoul National University Hospital | ||||||||||||||||
| Verification Date | November 2006 | ||||||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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