Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NACP 1
Study information
Scientific title
Acronym
NAC as a Nephroprotective agent in Peripheral Angiography
Study hypothesis
To investigate the role of N-acetylcysteine as a nephroprotective agent in patients undergoing peripheral angiography.
Ethics approval
Ethics approval received from the Cambridge Research Ethics Committee on the 24th November 2006 (ref: 06/QI0108/352).
Study design
Prospective randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Contrast induced nephropathy
Intervention
Treatment group:
Patients will be given 600 mg twice daily N-acetylcysteine the day before the angiogram, and 600 mg twice on the day of the angiogram with intravenous fluids. Samples of urine and blood will be collected before the angiogram and first, second and third day post angiography.
Control group:
Patients will only get intravenous hydration as per normal protocol and will have samples taken like the treatment arm patients.
Intervention type
Drug
Phase
Not Specified
Drug names
N-acetylcysteine
Primary outcome measure
Primarily we are looking for a reduction in the elevation in Albumin/Creatinine ratio and also of other markers of renal damage in urine (retinol binding protein), using the samples collected before the angiogram and first, second and third day post angiography.
Secondary outcome measures
A reduction in the mortality and morbidity related to renal failure that may result secondary to contrast solution used in angiography; this 30-day mortality morbidity reduction will be measured on follow up in clinic normally four to six weeks post angiography.
Overall trial start date
01/05/2007
Overall trial end date
01/05/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Any patient undergoing peripheral angiography in the Cambridge Vascular Unit, Addenbrookes Hospital, Cambridge who consents to participation.
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
Initially 40 patients in pilot study
Participant exclusion criteria
1. Any patient undergoing peripheral angiography in Cambridge Vascular Unit
2. Any patient that does not consent to participation in the study
3. Any patient under the age of 18 years
4. Any patient with established renal failure on renal replacement therapy (dialysis)
Recruitment start date
01/05/2007
Recruitment end date
01/05/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Box 201
Cambridge
CB2 2QQ
United Kingdom
Sponsor information
Organisation
Cambridge University Hospital NHS Trust (UK)
Sponsor details
Research & Development Department
Addenbrookes Hospital
Cambridge
CB2 2QQ
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation 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
2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20682612
Publication citations
-
Results
Sadat U, Walsh SR, Norden AG, Gillard JH, Boyle JR, Does oral N-acetylcysteine reduce contrast-induced renal injury in patients with peripheral arterial disease undergoing peripheral angiography? A randomized-controlled study., Angiology, 2011, 62, 3, 225-230, doi: 10.1177/0003319710377078.