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

Chronic Kidney Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00399256
• Other study ID #: IKP201
• Status: Terminated
• Phase: N/A
• First received: November 13, 2006
• Last updated: January 31, 2007
• Start date: March 2004
• Est. completion date: March 2006

Study information

• Verified date: January 2007
• Source: Robert Bosch Gesellschaft für Medizinische Forschung mbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Regierungspräsidium Stuttgart
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 60
• Est. completion date: March 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chronic Kidney Failure
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency

Intervention

Drug:
• Acetylcysteine

• Zinc

Locations

Country	Name	City	State
Germany	Robert-Bosch-Hospital	Stuttgart

Sponsors (1)

Lead Sponsor	Collaborator
Robert Bosch Gesellschaft für Medizinische Forschung mbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of acute renal failure
Secondary	Rise in creatinine of > 0.5 mg/dl
Secondary	Rise in creatinine > 25%
Secondary	Significant rise in serum cystatin C)