Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0256108007
Study information
Scientific title
Acronym
Study hypothesis
To assess if administration of N-acetylcysteine prevents or reduces the risk of acute renal damage following administration of radiographic contrast media in patients with vascular disease undergoing angiography/angioplasty.
Ethics approval
Not provided at time of registration
Study design
Randomised double blind placebo controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Condition
Urological and Genital Diseases: Renal injury
Intervention
Intravenous N-acetylcysteine vs placebo
Intervention type
Drug
Phase
Not Specified
Drug names
N-acetylcysteine
Primary outcome measure
Service outcomes development.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/03/2002
Overall trial end date
01/12/2003
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
100 patients
Participant type
Patient
Age group
Not Specified
Gender
Both
Target number of participants
100
Participant exclusion criteria
Does not meet inclusion criteria.
Recruitment start date
01/03/2002
Recruitment end date
01/12/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University Department of Surgery
London
NW3 2QG
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
The Royal Free Hampstead NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2004 results in http://www.ncbi.nlm.nih.gov/pubmed/15622367
Publication citations
-
Results
Rashid ST, Salman M, Myint F, Baker DM, Agarwal S, Sweny P, Hamilton G, Prevention of contrast-induced nephropathy in vascular patients undergoing angiography: a randomized controlled trial of intravenous N-acetylcysteine., J. Vasc. Surg., 2004, 40, 6, 1136-1141, doi: 10.1016/j.jvs.2004.09.026.