Does prophylactic N-AcetylCysteine decrease incidence of contrast nephropathy in patients undergoing peripheral angiography?
| ISRCTN | ISRCTN35882618 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN35882618 |
| Secondary identifying numbers | NACP 1 |
- Submission date
- 30/04/2007
- Registration date
- 02/08/2007
- Last edited
- 06/08/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Jonathan Boyle
Scientific
Scientific
Box 201
Cambridge Vascular Unit
Department of General Surgery
Addenbrookes Hospital
Hills Road
Cambridge
CB2 2QQ
United Kingdom
Study information
| Study design | Prospective randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study acronym | NAC as a Nephroprotective agent in Peripheral Angiography |
| Study objectives | To investigate the role of N-acetylcysteine as a nephroprotective agent in patients undergoing peripheral angiography. |
| Ethics approval(s) | Ethics approval received from the Cambridge Research Ethics Committee on the 24th November 2006 (ref: 06/QI0108/352). |
| Health condition(s) or problem(s) studied | Contrast induced nephropathy |
| Intervention | 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. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | N-acetylcysteine |
| Primary outcome measure | 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 measures | 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. |
| Overall study start date | 01/05/2007 |
| Completion date | 01/05/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target number of participants | Initially 40 patients in pilot study |
| Key inclusion criteria | Any patient undergoing peripheral angiography in the Cambridge Vascular Unit, Addenbrookes Hospital, Cambridge who consents to participation. |
| Key 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) |
| Date of first enrolment | 01/05/2007 |
| Date of final enrolment | 01/05/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Box 201
Cambridge
CB2 2QQ
United Kingdom
CB2 2QQ
United Kingdom
Sponsor information
Cambridge University Hospital NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Research & Development Department
Addenbrookes Hospital
Cambridge
CB2 2QQ
England
United Kingdom
| Website | http://www.addenbrookes.org.uk/ |
|---|---|
"ROR" |
https://ror.org/04v54gj93 |
Funders
Funder type
Government
Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust (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 | 01/04/2011 | Yes | No |
