Back to resultsImproved Estimation of GFR by Cystatin C in Preventing Contrast Induced Nephropathy by NAC or Zn
Primary Purpose
Chronic Kidney Failure
Status
Terminated
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Acetylcysteine
Zinc
Sponsored by
About this trial
This is an interventional prevention trial for Chronic Kidney Failure focused on measuring contrast-induced nephropathy, Acetylcysteine, Zinc, Cystatin C, Creatinine
Eligibility Criteria
Inclusion Criteria:
- older than 18 years of age,
- serum creatinine > 1.2 mg/dl or a creatinine clearance < 50 ml/min (measured by a 12 or 24 hour urine collection).
Exclusion Criteria:
- acute inflammatory disease,
- medication with NSAID or metformin until 3 days before entering study,
- abnormal findings in physical examinations, e.g. signs of dehydration or decompensated heart failure.
Sites / Locations
- Robert-Bosch-Hospital
Outcomes
Primary Outcome Measures
Incidence of acute renal failure
Secondary Outcome Measures
Rise in creatinine of > 0.5 mg/dl
Rise in creatinine > 25%
Significant rise in serum cystatin C)
Full Information
NCT ID
NCT00399256
First Posted
November 13, 2006
Last Updated
January 31, 2007
Sponsor
Robert Bosch Gesellschaft für Medizinische Forschung mbH
1. Study Identification
Unique Protocol Identification Number
NCT00399256
Brief Title
Improved Estimation of GFR by Cystatin C in Preventing Contrast Induced Nephropathy by NAC or Zn
Official Title
Improved Estimation of Glomerular Filtration Rate by Serum Cystatin C in Preventing Contrast Induced Nephropathy by N-Acetylcysteine or Zinc
Study Type
Interventional
2. Study Status
Record Verification Date
January 2007
Overall Recruitment Status
Terminated
Study Start Date
March 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Robert Bosch Gesellschaft für Medizinische Forschung mbH
4. Oversight
5. Study Description
Brief Summary
Background Prevention of contrast media (CM) induced nephropathy (CIN) by pharmacological prophylaxis (e.g. 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 1.2g/day of NAC (n=19), for 1 day with 60mg/day of Zn (n=18) or placebo (n=17). All patients were periprocedural hydrated with 1ml/kg/h of 0.45% 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Failure
Keywords
contrast-induced nephropathy, Acetylcysteine, Zinc, Cystatin C, Creatinine
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
60 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Acetylcysteine
Intervention Type
Drug
Intervention Name(s)
Zinc
Primary Outcome Measure Information:
Title
Incidence of acute renal failure
Secondary Outcome Measure Information:
Title
Rise in creatinine of > 0.5 mg/dl
Title
Rise in creatinine > 25%
Title
Significant rise in serum cystatin C)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
older than 18 years of age,
serum creatinine > 1.2 mg/dl or a creatinine clearance < 50 ml/min (measured by a 12 or 24 hour urine collection).
Exclusion Criteria:
acute inflammatory disease,
medication with NSAID or metformin until 3 days before entering study,
abnormal findings in physical examinations, e.g. signs of dehydration or decompensated heart failure.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dominik M Alscher, MD
Organizational Affiliation
Robert-Bosch-Hospital, Stuttgart, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Robert-Bosch-Hospital
City
Stuttgart
ZIP/Postal Code
D-70376
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
28302075
Citation
Schanz M, Schaaf L, Dippon J, Biegger D, Fritz P, Alscher MD, Kimmel M. Renal effects of metallothionein induction by zinc in vitro and in vivo. BMC Nephrol. 2017 Mar 16;18(1):91. doi: 10.1186/s12882-017-0503-z.
Results Reference
derived
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Improved Estimation of GFR by Cystatin C in Preventing Contrast Induced Nephropathy by NAC or Zn
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