Ignite Creation Date:
2024-05-05 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00399256
Status:
TERMINATED
Last Update Posted:
2007-02-01
First Post:
2006-11-13
Brief Title:
Improved Estimation of GFR by Cystatin C in Preventing Contrast Induced Nephropathy by NAC or Zn
Sponsor:
Robert Bosch Gesellschaft für Medizinische Forschung mbH
Organization:
Robert Bosch Gesellschaft für Medizinische Forschung mbH
Study Overview
Official Title:
Improved Estimation of Glomerular Filtration Rate by Serum Cystatin C in Preventing Contrast Induced Nephropathy by N-Acetylcysteine or Zinc
Status:
TERMINATED
Status Verified Date:
2007-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background Prevention of contrast media CM induced nephropathy CIN by pharmacological prophylaxis eg N-acetylcysteine NAC is controversially discussed So far in all interventional studies assessment of kidney function was based on measurements of serum creatinine although this surrogate biomarker has several limitations We investigated the antioxidants NAC and zinc Zn for the prevention of CIN by monitoring concomitantly serum levels of creatinine and cystatin C
Detailed Description:
In a prospective placebo-controlled double blind trial patients with moderate impaired kidney function receiving hypoosmolar nonionic contrast medium were randomly assigned to an oral treatment for 2 days with 12gday of NAC n19 for 1 day with 60mgday of Zn n18 or placebo n17 All patients were periprocedural hydrated with 1mlkgh of 045 saline for 24h At baseline before hydration prior to exposure of CM as well as 2 and 6 days after CM serum levels of creatinine and cystatin C have been measured
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None