Contact information
Type
Scientific
Primary contact
Mr J Boyle
ORCID ID
Contact details
Cambridge Vascular Unit
Dept. of General Surgery
Box 201
Addenbrooke's Hospital
Cambridge
CB2 2QQ
United Kingdom
+44 (0)1223 217246
jonathan.boyle@addenbrookes.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0544139644
Study information
Scientific title
Acronym
Study hypothesis
Is peri-operative oral N acetylcysteine nephroprotective in patients undergoing endovascular abdominal aortic aneurysm repair?
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
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Surgery: Abdominal aortic aneurysm (AAA) repair
Intervention
Participation offered to all patients undergoing endovascular abdominal aortic aneurysm repair in the Cambridge Vascular Unit, Addenbrooke's Hospital. Consenting patients will be randomised to receive either intra venous saline hydration (current practice) or intravenous saline hydration and oral N acetyl-cysteine (600 mg twice a day (bd) orally (PO) on the day before the procedure; and 600 mg bd PO on the day of the procedure, one dose before, and one dose after the procedure). Evidence of renal injury will be monitored post-procedure by assay of serum creatinine levels, and also by measuring urinary low molecular weight proteins such as N acetyl beta glucosaminidase (NAG) a subclinical marker of renal injury, and albumin and creatinine.
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
16/12/2003
Overall trial end date
15/12/2006
Reason abandoned
Eligibility
Participant inclusion criteria
Not provided at time of registration
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
20
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
16/12/2003
Recruitment end date
15/12/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Cambridge Vascular Unit
Cambridge
CB2 2QQ
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Cambridge Consortium - Addenbrooke's (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
2006 results on http://www.ncbi.nlm.nih.gov/pubmed/17042662
Publication citations
-
Results
Moore NN, Lapsley M, Norden AG, Firth JD, Gaunt ME, Varty K, Boyle JR, Does N-acetylcysteine prevent contrast-induced nephropathy during endovascular AAA repair? A randomized controlled pilot study., J. Endovasc. Ther., 2006, 13, 5, 660-666, doi: 10.1583/06-1833.1.