Condition category
Urological and Genital Diseases
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
03/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr George Hamilton

ORCID ID

Contact details

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

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 measures

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

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

http://www.doh.gov.uk

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

Results - basic reporting

Publication summary

2004 results in http://www.ncbi.nlm.nih.gov/pubmed/15622367

Publication citations

  1. 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.

Additional files

Editorial Notes