Evaluation of Intravenous N-acetylcysteine to Prevent Contrast Media Induced Nephrotoxicity in an Emergency Center
Does Ultra-High Dose i.v. N-acetylcysteine Prevent Contrast Nephropathy in Patients With Chronic Kidney Disease Undergoing Emergency Contrast Tomography.
1 other identifier
observational
124
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2008
Typical duration for all trials
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
May 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 3, 2011
CompletedFirst Posted
Study publicly available on registry
November 8, 2011
CompletedNovember 9, 2011
November 1, 2011
2.5 years
November 3, 2011
November 8, 2011
Conditions
Outcome Measures
Primary Outcomes (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.
10 days
Secondary Outcomes (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).
10 days
Study Arms (2)
Control group
NAC group
Eligibility Criteria
emergency center patients
You may qualify if:
- Renal failure and need of contrast enhanced CT
You may not qualify if:
- Asthma
- Pregnancy
- Obstructive nephropathy
- Patient or family's refusal
- In all patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Poletti PA, Platon A, De Seigneux S, Dupuis-Lozeron E, Sarasin F, Becker CD, Perneger T, Saudan P, Martin PY. N-acetylcysteine does not prevent contrast nephropathy in patients with renal impairment undergoing emergency CT: a randomized study. BMC Nephrol. 2013 Jun 3;14:119. doi: 10.1186/1471-2369-14-119.
PMID: 23731573DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Pierre-Alexandre Poletti, MD
University Hospital, Geneva
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
November 3, 2011
First Posted
November 8, 2011
Study Start
May 1, 2008
Primary Completion
November 1, 2010
Study Completion
November 1, 2011
Last Updated
November 9, 2011
Record last verified: 2011-11