Prevention of radiographic contrast media induced renal injury by administration of intravenous N-acetylcysteine in vascular patients undergoing angiography/angioplasty

ISRCTN ISRCTN34443742
DOI https://doi.org/10.1186/ISRCTN34443742
Secondary identifying numbers N0256108007
Submission date
12/09/2003
Registration date
12/09/2003
Last edited
03/08/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr George Hamilton
Scientific

University Department of Surgery
Royal Free Hampstead NHS Trust
Pond Street
Hampstead
London
NW3 2QG
United Kingdom

Study information

Study designRandomised double blind placebo controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typePrevention
Scientific title
Study objectivesTo 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedUrological and Genital Diseases: Renal injury
InterventionIntravenous N-acetylcysteine vs placebo
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)N-acetylcysteine
Primary outcome measureService outcomes development.
Secondary outcome measuresNot provided at time of registration
Overall study start date01/03/2002
Completion date01/12/2003

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexBoth
Target number of participants100
Key inclusion criteria100 patients
Key exclusion criteriaDoes not meet inclusion criteria.
Date of first enrolment01/03/2002
Date of final enrolment01/12/2003

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

University Department of Surgery
London
NW3 2QG
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website http://www.doh.gov.uk

Funders

Funder type

Hospital/treatment centre

The Royal Free Hampstead NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/12/2004 Yes No