NCT00399256

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2004

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 13, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 14, 2006

Completed
Last Updated

February 1, 2007

Status Verified

January 1, 2007

First QC Date

November 13, 2006

Last Update Submit

January 31, 2007

Conditions

Chronic Kidney Failure

Keywords

contrast-induced nephropathyAcetylcysteineZincCystatin CCreatinine

Outcome Measures

Primary Outcomes (1)

  • Incidence of acute renal failure

Secondary Outcomes (3)

  • Rise in creatinine of > 0.5 mg/dl

  • Rise in creatinine > 25%

  • Significant rise in serum cystatin C)

Interventions

AcetylcysteineDRUG
ZincDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Robert-Bosch-Hospital

Stuttgart, D-70376, Germany

Location

Related Publications (1)

  • Schanz M, Schaaf L, Dippon J, Biegger D, Fritz P, Alscher MD, Kimmel M. Renal effects of metallothionein induction by zinc in vitro and in vivo. BMC Nephrol. 2017 Mar 16;18(1):91. doi: 10.1186/s12882-017-0503-z.

    PMID: 28302075DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

AcetylcysteineZinc

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CysteineAmino Acids, SulfurSulfur CompoundsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and ProteinsMetals, HeavyElementsInorganic ChemicalsTransition ElementsMetals

Study Officials

  • Dominik M Alscher, MD

    Robert-Bosch-Hospital, Stuttgart, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 13, 2006

First Posted

November 14, 2006

Study Start

March 1, 2004

Study Completion

March 1, 2006

Last Updated

February 1, 2007

Record last verified: 2007-01

Locations

DE(1)