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Clinical Trials/NCT00399256
NCT00399256TerminatedNot Applicable

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

Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)2 sites in 1 country60 target enrollmentStarted: March 1, 2004Last updated:
Conditions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
60
Locations
2
Primary Endpoint
Incidence of acute renal failure

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Double

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
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.

Outcomes

Primary Outcomes

Incidence of acute renal failure

Secondary Outcomes

  • Rise in creatinine of > 0.5 mg/dl
  • Rise in creatinine > 25%
  • Significant rise in serum cystatin C)

Investigators

Study Sites (2)

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