|
ISRCTN
|
ISRCTN35882618
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Does prophylactic N-AcetylCysteine decrease incidence of contrast nephropathy in patients undergoing peripheral angiography?
|
|
Scientific title
|
|
|
Acronym
|
NAC as a Nephroprotective agent in Peripheral Angiography
|
|
Serial number at source
|
NACP 1
|
|
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
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Contrast induced nephropathy
|
|
Participants - inclusion criteria
|
Any patient undergoing peripheral angiography in the Cambridge Vascular Unit, Addenbrooke’s Hospital, Cambridge who consents to participation.
|
|
Participants - 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)
|
|
Anticipated start date
|
01/05/2007
|
|
Anticipated end date
|
01/05/2008
|
|
Status of trial
|
Completed
|
|
Patient information material
|
|
|
Target number of participants
|
Initially 40 patients in pilot study
|
|
Interventions
|
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.
|
|
Primary outcome measure(s)
|
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 measure(s)
|
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.
|
|
Sources of funding
|
Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust (UK)
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Mr
Jonathan
Boyle
|
|
Address
|
Box 201
Cambridge Vascular Unit
Department of General Surgery
Addenbrooke’s Hospital
Hills Road
|
|
City/town
|
Cambridge
|
|
Zip/Postcode
|
CB2 2QQ
|
|
Country
|
United Kingdom
|
|
Sponsor
|
Cambridge University Hospital NHS Trust (UK)
|
|
Address
|
Research & Development Department
Addenbrooke’s Hospital
|
|
City/town
|
Cambridge
|
|
Zip/Postcode
|
CB2 2QQ
|
|
Country
|
United Kingdom
|
|
Sponsor website:
|
http://www.addenbrookes.org.uk/
|
|
Date applied
|
30/04/2007
|
|
Last edited
|
02/08/2007
|
|
Date ISRCTN assigned
|
02/08/2007
|
