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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:

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.

Condition or disease Intervention/treatment
Chronic Kidney Failure Drug: Acetylcysteine Drug: Zinc

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
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
Study Start Date : March 2004
Estimated Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Incidence of acute renal failure

Secondary Outcome Measures :
  1. Rise in creatinine of > 0.5 mg/dl
  2. Rise in creatinine > 25%
  3. Significant rise in serum cystatin C)

Eligibility Criteria

Information from the National Library of Medicine

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

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00399256


Locations
Germany
Robert-Bosch-Hospital
Stuttgart, Germany, D-70376
Sponsors and Collaborators
Robert Bosch Gesellschaft für Medizinische Forschung mbH
Investigators
Principal Investigator: Dominik M Alscher, MD Robert-Bosch-Hospital, Stuttgart, Germany
More Information

ClinicalTrials.gov Identifier: NCT00399256     History of Changes
Other Study ID Numbers: IKP201
First Posted: November 14, 2006    Key Record Dates
Last Update Posted: February 1, 2007
Last Verified: January 2007

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

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Zinc
Acetylcysteine
N-monoacetylcystine
Cystatins
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Antidotes
Cysteine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors