The effect of N-acetylcysteine (NAC) on renal functions of patients undergoing cardiac catheterisation
| ISRCTN | ISRCTN41934493 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN41934493 |
| Secondary identifying numbers | N0176115665 |
- 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
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | N-acetylcysteine (NAC |
| Primary outcome measure | 1. Change in serum creatinine (short and medium term) 2. VCAM-1 and isoprostanes 3. Length of hospital stay 4. Need for dialysis |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 15/07/2002 |
| 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 number of participants | 28 patients, 28 controls, total 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
- England
- United Kingdom
Study participating centre
Department of Cardiology
Oxford
OX3 9DU
United Kingdom
OX3 9DU
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Government
Oxford Radcliffe Hospitals NHS 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 |
