The effect of N-acetylcysteine (NAC) on renal functions of patients undergoing cardiac catheterisation
| ISRCTN | ISRCTN41934493 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN41934493 |
| Protocol serial number | N0176115665 |
| Sponsor | Department of Health (UK) |
| Funder | Oxford Radcliffe Hospitals NHS Trust (UK) |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 27/09/2011
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Adrian P Banning
Scientific
Scientific
Department of Cardiology
John Radcliffe Hospital
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
| Phone | +44 01865 220235 |
|---|---|
| adrian.banning@orh.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Contrast material administration in cardiac catheterisation (angiogram/angioplasty) is associated with a deterioration in kidney function of some patients with underlying renal impairment. Recent studies suggest that NAC may reduce such complication but it is not clear whether this effect is sustained for long periods or clinically relevant. We therefore would like to propose a study to find out the medium term effect of NAC on the kidney functions of these patients and their clinical relevances. In addition, we would also like to investigate whether there is any significant change in blood markers of inflammation such as vascular cell adhesion molecule-1 (VCAM-1) and isoprostanes with the use of NAC in this group of patients. This may help to explain the mechanism of contrast material induced kidney injury and protective effect of NAC. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Urological and Genital Diseases: Renal function |
| Intervention | Not provided at time of registration. Added June 2008: trial abandoned. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | N-acetylcysteine (NAC |
| Primary outcome measure(s) |
1. Change in serum creatinine (short and medium term) |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/05/2004 |
| Reason abandoned (if study stopped) | Poor recruitment |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 56 |
| Key inclusion criteria | Not provided at time of registration |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 15/07/2002 |
| Date of final enrolment | 31/05/2004 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Department of Cardiology
Oxford
OX3 9DU
United Kingdom
OX3 9DU
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 |
