|
ISRCTN
|
ISRCTN69248640
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Does prophylactic N acetylcysteine decrease the incidence of contrast nephropathy in patients undergoing endovascular abdominal aortic aneurysm (AAA) repair?
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
N0544139644
|
|
Study hypothesis
|
Is peri-operative oral N acetylcysteine nephroprotective in patients undergoing endovascular abdominal aortic aneurysm repair?
|
|
Lay summary
|
|
|
Ethics approval
|
Not provided at time of registration
|
|
Study design
|
Randomised controlled trial
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Surgery: Abdominal aortic aneurysm (AAA) repair
|
|
Participants - inclusion criteria
|
Not provided at time of registration
|
|
Participants - exclusion criteria
|
Not provided at time of registration
|
|
Anticipated start date
|
16/12/2003
|
|
Anticipated end date
|
15/12/2006
|
|
Status of trial
|
Completed |
|
Patient information material
|
|
|
Target number of participants
|
20
|
|
Interventions
|
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.
|
|
Primary outcome measure(s)
|
Not provided at time of registration
|
|
Secondary outcome measure(s)
|
Not provided at time of registration
|
|
Sources of funding
|
Cambridge Consortium - Addenbrooke's (UK)
|
|
Trial website
|
|
|
Publications
|
2006 results on http://www.ncbi.nlm.nih.gov/pubmed/17042662
|
|
Contact name
|
Mr
J
Boyle
|
|
Address
|
Cambridge Vascular Unit
Dept. of General Surgery
Box 201
Addenbrooke's Hospital
|
|
City/town
|
Cambridge
|
|
Zip/Postcode
|
CB2 2QQ
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)1223 217246
|
|
Fax
|
+44 (0)1223 216015
|
|
Email
|
jonathan.boyle@addenbrookes.nhs.uk
|
|
Sponsor
|
Record Provided by the NHSTCT Register - 2004 Update - Department of Health (UK)
|
|
Address
|
The Department of Health,
Richmond House,
79 Whitehall
|
|
City/town
|
London
|
|
Zip/Postcode
|
SW1A 2NL
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)20 7307 2622
|
|
Email
|
dhmail@doh.gsi.org.uk
|
|
Sponsor website:
|
http://www.dh.gov.uk/Home/fs/en
|
|
Date applied
|
30/09/2004
|
|
Last edited
|
18/02/2008
|
|
Date ISRCTN assigned
|
30/09/2004
|
