Prevention of radiographic contrast media induced renal injury by administration of intravenous N-acetylcysteine in vascular patients undergoing angiography/angioplasty
| ISRCTN | ISRCTN34443742 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN34443742 |
| Protocol serial number | N0256108007 |
| Sponsor | Department of Health (UK) |
| Funder | The Royal Free Hampstead NHS Trust (UK) |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 03/08/2009
- 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 George Hamilton
Scientific
Scientific
University Department of Surgery
Royal Free Hampstead NHS Trust
Pond Street
Hampstead
London
NW3 2QG
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised double blind placebo controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | To assess if administration of N-acetylcysteine prevents or reduces the risk of acute renal damage following administration of radiographic contrast media in patients with vascular disease undergoing angiography/angioplasty. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Urological and Genital Diseases: Renal injury |
| Intervention | Intravenous N-acetylcysteine vs placebo |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | N-acetylcysteine |
| Primary outcome measure(s) |
Service outcomes development. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/12/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | All |
| Target sample size at registration | 100 |
| Key inclusion criteria | 100 patients |
| Key exclusion criteria | Does not meet inclusion criteria. |
| Date of first enrolment | 01/03/2002 |
| Date of final enrolment | 01/12/2003 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
University Department of Surgery
London
NW3 2QG
United Kingdom
NW3 2QG
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | 01/12/2004 | Yes | No |
