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Evaluation of Intravenous N-acetylcysteine to Prevent Contrast Media Induced Nephrotoxicity in an Emergency Center

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Poletti Pierre-Alexandre, University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT01467154
First received: November 3, 2011
Last updated: November 8, 2011
Last verified: November 2011
History of Changes
  Purpose

The aim of the present study is to determine whether a high dose of intravenous NAC is efficient in preventing CN after emergency contrast injection in patients with renal failure.


Condition
Nephrotoxicity

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Does Ultra-High Dose i.v. N-acetylcysteine Prevent Contrast Nephropathy in Patients With Chronic Kidney Disease Undergoing Emergency Contrast Tomography.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:
  • occurrence of contrast nephropathy at day 2, 4 or 10, which was defined as an increase of at least 25% and/or 44 umol/l in serum creatinine level or cystatine C levels at day 2, 4 or 10 compared to day 0. [ Time Frame: 10 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • mean increases in creatinine and cystatin C concentrations on days 2, 4 and 10 and maximum increase during the time periods from day 2 to day 10 (peak increase). [ Time Frame: 10 days ] [ Designated as safety issue: No ]

Enrollment: 124
Study Start Date: May 2008
Study Completion Date: November 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Control group
NAC group

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

emergency center patients

Criteria

Inclusion Criteria:

  • Renal failure and need of contrast enhanced CT

Exclusion Criteria:

  • Asthma
  • Pregnancy
  • Obstructive nephropathy
  • Patient or family's refusal
  • In all patients
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01467154

Sponsors and Collaborators
University Hospital, Geneva
Investigators
Principal Investigator: Pierre-Alexandre Poletti, MD University Hospital, Geneva
  More Information

No publications provided

Responsible Party: Poletti Pierre-Alexandre, MD, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT01467154     History of Changes
Other Study ID Numbers: 2008DR4057
Study First Received: November 3, 2011
Last Updated: November 8, 2011
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Emergencies
Renal Insufficiency, Chronic
Disease Attributes
Pathologic Processes
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
 Therapeutic Uses
Pharmacologic Actions
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes

ClinicalTrials.gov processed this record on May 19, 2013