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

Improved Estimation of Glomerular Filtration Rate by Serum Cystatin C in Preventing Contrast Induced Nephropathy by N-Acetylcysteine or Zinc

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00399256

Enrollment

Registered

2006-11-14

Start date

2004-03-31

Completion date

2006-03-31

Last updated

2007-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Failure

Keywords

contrast-induced nephropathy, Acetylcysteine, Zinc, Cystatin C, Creatinine

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.

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.

Interventions

DRUGAcetylcysteine

DRUGZinc

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Incidence of acute renal failure	—

Secondary

Measure	Time frame
Rise in creatinine of > 0.5 mg/dl	—
Rise in creatinine > 25%	—
Significant rise in serum cystatin C)	—

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026