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Trial record 1 of 1 for:    2008DR4057
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Evaluation of Intravenous N-acetylcysteine to Prevent Contrast Media Induced Nephrotoxicity in an Emergency Center

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01467154
Recruitment Status : Completed
First Posted : November 8, 2011
Last Update Posted : November 9, 2011
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

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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

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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
emergency center patients

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 identifier (NCT number): NCT01467154

Sponsors and Collaborators
University Hospital, Geneva
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Principal Investigator: Pierre-Alexandre Poletti, MD University Hospital, Geneva
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Poletti Pierre-Alexandre, MD, University Hospital, Geneva Identifier: NCT01467154    
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:
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Disease Attributes
Pathologic Processes