Contact information
Type
Scientific
Primary contact
Dr Adrian P Banning
ORCID ID
Contact details
Department of Cardiology
John Radcliffe Hospital
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
+44 01865 220235
adrian.banning@orh.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0176115665
Study information
Scientific title
Acronym
Study hypothesis
Contrast material administration in cardiac catheterisation (angiogram/angioplasty) is associated with a deterioration in kidney function of some patients with underlying renal impairment. Recent studies suggest that NAC may reduce such complication but it is not clear whether this effect is sustained for long periods or clinically relevant. We therefore would like to propose a study to find out the medium term effect of NAC on the kidney functions of these patients and their clinical relevances. In addition, we would also like to investigate whether there is any significant change in blood markers of inflammation such as vascular cell adhesion molecule-1 (VCAM-1) and isoprostanes with the use of NAC in this group of patients. This may help to explain the mechanism of contrast material induced kidney injury and protective effect of NAC.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Urological and Genital Diseases: Renal function
Intervention
Not provided at time of registration.
Added June 2008: trial abandoned.
Intervention type
Drug
Phase
Not Specified
Drug names
N-acetylcysteine (NAC
Primary outcome measures
1. Change in serum creatinine (short and medium term)
2. VCAM-1 and isoprostanes
3. Length of hospital stay
4. Need for dialysis
Secondary outcome measures
Not provided at time of registration
Overall trial start date
15/07/2002
Overall trial end date
31/05/2004
Reason abandoned
Poor recruitment
Eligibility
Participant inclusion criteria
Not provided at time of registration
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
28 patients, 28 controls, total 56
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
15/07/2002
Recruitment end date
31/05/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Cardiology
Oxford
OX3 9DU
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
Government
Funder name
Oxford Radcliffe Hospitals 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