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

This study has been terminated.
Sponsor:
Information provided by:
Robert Bosch Gesellschaft für Medizinische Forschung mbH
ClinicalTrials.gov Identifier:
NCT00399256
First received: November 13, 2006
Last updated: January 31, 2007
Last verified: January 2007
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00399256     History of Changes
Other Study ID Numbers: IKP201
Study First Received: November 13, 2006
Last Updated: January 31, 2007
Health Authority: Germany: Regierungspräsidium Stuttgart

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

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

ClinicalTrials.gov processed this record on April 17, 2014