- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00399256
Improved Estimation of GFR by Cystatin C in Preventing Contrast Induced Nephropathy by NAC or Zn
January 31, 2007 updated by: Robert Bosch Gesellschaft für Medizinische Forschung mbH
Improved Estimation of Glomerular Filtration Rate by Serum Cystatin C in Preventing Contrast Induced Nephropathy by N-Acetylcysteine or Zinc
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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
Interventional
Enrollment
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Stuttgart, Germany, D-70376
- Robert-Bosch-Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Incidence of acute renal failure
|
Secondary Outcome Measures
Outcome Measure |
---|
Rise in creatinine of > 0.5 mg/dl
|
Rise in creatinine > 25%
|
Significant rise in serum cystatin C)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Dominik M Alscher, MD, Robert-Bosch-Hospital, Stuttgart, Germany
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2004
Study Completion
March 1, 2006
Study Registration Dates
First Submitted
November 13, 2006
First Submitted That Met QC Criteria
November 13, 2006
First Posted (Estimate)
November 14, 2006
Study Record Updates
Last Update Posted (Estimate)
February 1, 2007
Last Update Submitted That Met QC Criteria
January 31, 2007
Last Verified
January 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urologic Diseases
- Renal Insufficiency, Chronic
- Kidney Diseases
- Kidney Failure, Chronic
- Renal Insufficiency
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Protective Agents
- Respiratory System Agents
- Antioxidants
- Antidotes
- Free Radical Scavengers
- Expectorants
- Acetylcysteine
- N-monoacetylcystine
Other Study ID Numbers
- IKP201
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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