Does prophylactic N acetylcysteine decrease the incidence of contrast nephropathy in patients undergoing endovascular abdominal aortic aneurysm (AAA) repair?

ISRCTN	ISRCTN69248640
DOI	https://doi.org/10.1186/ISRCTN69248640
Protocol serial number	N0544139644
Sponsor	Department of Health
Funder	Cambridge Consortium - Addenbrooke's (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Mr J Boyle
Scientific

Cambridge Vascular Unit
Dept. of General Surgery
Box 201
Addenbrooke's Hospital
Cambridge
CB2 2QQ
United Kingdom

Phone	+44 (0)1223 217246
Email	jonathan.boyle@addenbrookes.nhs.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Is peri-operative oral N acetylcysteine nephroprotective in patients undergoing endovascular abdominal aortic aneurysm repair?
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	15/12/2006

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	20
Key inclusion criteria	Not provided at time of registration
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	16/12/2003
Date of final enrolment	15/12/2006

Cambridge Vascular Unit

Cambridge
CB2 2QQ
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/10/2006		Yes	No