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Improved Estimation of GFR by Cystatin C in Preventing Contrast Induced Nephropathy by NAC or Zn

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ClinicalTrials.gov Identifier: NCT00399256
Recruitment Status : Terminated
First Posted : November 14, 2006
Last Update Posted : February 1, 2007
Sponsor:
Information provided by:
Robert Bosch Gesellschaft für Medizinische Forschung mbH

Tracking Information
First Submitted Date  ICMJE November 13, 2006
First Posted Date  ICMJE November 14, 2006
Last Update Posted Date February 1, 2007
Study Start Date  ICMJE March 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: November 13, 2006)
Incidence of acute renal failure
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00399256 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2007)
  • Rise in creatinine of > 0.5 mg/dl
  • Rise in creatinine > 25%
  • Significant rise in serum cystatin C)
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Improved Estimation of GFR by Cystatin C in Preventing Contrast Induced Nephropathy by NAC or Zn
Official Title  ICMJE Improved Estimation of Glomerular Filtration Rate by Serum Cystatin C in Preventing Contrast Induced Nephropathy by N-Acetylcysteine or Zinc
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Condition  ICMJE Chronic Kidney Failure
Intervention  ICMJE
  • Drug: Acetylcysteine
  • Drug: Zinc
Study Arms  ICMJE Not Provided
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Enrollment  ICMJE
 (submitted: November 13, 2006)
60
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE March 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. older than 18 years of age,
  2. serum creatinine > 1.2 mg/dl or a creatinine clearance < 50 ml/min (measured by a 12 or 24 hour urine collection).

Exclusion Criteria:

  1. acute inflammatory disease,
  2. medication with NSAID or metformin until 3 days before entering study,
  3. abnormal findings in physical examinations, e.g. signs of dehydration or decompensated heart failure.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00399256
Other Study ID Numbers  ICMJE IKP201
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Robert Bosch Gesellschaft für Medizinische Forschung mbH
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dominik M Alscher, MD Robert-Bosch-Hospital, Stuttgart, Germany
PRS Account Robert Bosch Gesellschaft für Medizinische Forschung mbH
Verification Date January 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP