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

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ClinicalTrials.gov Identifier: NCT01467154
Recruitment Status : Completed
First Posted : November 8, 2011
Last Update Posted : November 9, 2011
Sponsor:
Information provided by (Responsible Party):
Poletti Pierre-Alexandre, University Hospital, Geneva

Brief Summary:
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 or disease
Nephrotoxicity

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 124 participants
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.
Study Start Date : May 2008
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
Control group
NAC group



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01467154


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Poletti Pierre-Alexandre, MD, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT01467154     History of Changes
Other Study ID Numbers: 2008DR4057
First Posted: November 8, 2011    Key Record Dates
Last Update Posted: November 9, 2011
Last Verified: November 2011

Additional relevant MeSH terms:
Emergencies
Disease Attributes
Pathologic Processes
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes