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 |
| Secondary identifying numbers | N0544139644 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 18/02/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr J Boyle
Scientific
Scientific
Cambridge Vascular Unit
Dept. of General Surgery
Box 201
Addenbrooke's Hospital
Cambridge
CB2 2QQ
United Kingdom
| Phone | +44 (0)1223 217246 |
|---|---|
| jonathan.boyle@addenbrookes.nhs.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 16/12/2003 |
| Completion date | 15/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Cambridge Vascular Unit
Cambridge
CB2 2QQ
United Kingdom
CB2 2QQ
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Government
Cambridge Consortium - Addenbrooke's (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/10/2006 | Yes | No |
