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

This study has been terminated.
Information provided by:
Robert Bosch Gesellschaft für Medizinische Forschung mbH Identifier:
First received: November 13, 2006
Last updated: January 31, 2007
Last verified: January 2007
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.

Condition Intervention
Chronic Kidney Failure Drug: Acetylcysteine Drug: Zinc

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Improved Estimation of Glomerular Filtration Rate by Serum Cystatin C in Preventing Contrast Induced Nephropathy by N-Acetylcysteine or Zinc

Resource links provided by NLM:

Further study details as provided by Robert Bosch Gesellschaft für Medizinische Forschung mbH:

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)

Estimated Enrollment: 60
Study Start Date: March 2004
Estimated Study Completion Date: March 2006
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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.
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Please refer to this study by its identifier: NCT00399256

Stuttgart, Germany, D-70376
Sponsors and Collaborators
Robert Bosch Gesellschaft für Medizinische Forschung mbH
Principal Investigator: Dominik M Alscher, MD Robert-Bosch-Hospital, Stuttgart, Germany
  More Information Identifier: NCT00399256     History of Changes
Other Study ID Numbers: IKP201
Study First Received: November 13, 2006
Last Updated: January 31, 2007

Keywords provided by Robert Bosch Gesellschaft für Medizinische Forschung mbH:
contrast-induced nephropathy
Cystatin C

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Trace Elements
Growth Substances
Physiological Effects of Drugs
Antiviral Agents
Anti-Infective Agents
Respiratory System Agents
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Protective Agents
Cysteine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors processed this record on September 19, 2017