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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Study Completion Date

2006-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Kidney Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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Acetylcysteine

Intervention Type DRUG

Zinc

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes