Improved Estimation of GFR by Cystatin C in Preventing Contrast Induced Nephropathy by NAC or Zn
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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 |
- Incidence of acute renal failure
- 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 |
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 |
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.
Contacts and Locations| Germany | |
| Robert-Bosch-Hospital | |
| Stuttgart, Germany, D-70376 | |
| 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 June 17, 2013