| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN71629284 |
| Date ISRCTN assigned | 21/08/2007 |
| Local reference number(s) | 07/Q1403/17 |
| Public title | Does N-Acetylcysteine (Parvolex®) prophylaxis reduce the incidence of renal impairment after onpump Coronary Artery Bypass Graft surgery? A prospective randomised controlled trial |
| Scientific title |
|
| Acronym | N-Acetylcysteine prophylaxis for onpump CABG |
| Disease/condition/study domain | Renal impairment |
| Study hypothesis | Prohylatic use of N-Acetylcysteine will decrease the incidence of renal failure in patients undergoing onpump Coronary Artery Bypass Graft (CABG) surgery. |
| Design/methodology | Prospective randomised double blind controlled trial |
| Research ethics review | Approved by South Manchester Research Ethics Committee (UK) on the 18th June 2007 (REC ref 07/Q1403/17). |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Patients undergoing elective coronoray artery bypass surgery (onpump) at Wythenshawe Hospital
2. Aged 21 - 80 years |
| Participants - exclusion criteria | 1. Urgent or emergency cases
2. History of hypersensitivity to N-Acetylcysteine
3. Patients already taking N-Acetylcysteine
4. Patients with renal failure |
| Patient information material |
|
| Anticipated start date | 01/08/2007 |
| Anticipated end date | 31/07/2008 |
| Status of trial | Ongoing |
| Target number of participants | 224 (112 in each group) |
| Interventions | For both groups, there will be no change in routine anaesthetic/surgical or post operative management.
The intervention group will be administered 2 g N-Acetylcysteine on the night before surgery (oral), 2 g at induction of anaesthesia (intravenous [IV]) and 2 g IV on the morning of first post operative day. The control group will receive placebos at the same time as the intervention group.
Patients will be followed up until discharge. |
| Primary outcome measure(s) | Creatinine clearance and serum creatinine levels on second and fifth post operative day and on discharge. |
| Secondary outcome measure(s) | Length of Intensive Care Unit (ICU) stay. |
| Sources of funding | University Hospital of South Manchester NHS Foundation Trust (UK) |
| Sponsor name | University Hospital of South Manchester NHS Foundation Trust (UK) |
| Sponsor details | Department of Research and Development
Wythenshawe Hospital
South Moore Road
Wythenshawe
Manchester
United Kingdom
M23 9LT |
| Sponsor telephone | +44 (0)161 291 5775 |
| Sponsor email | andrew.maines@manchester.ac.uk |
| Sponsor website | http://www.smuht.nwest.nhs.uk/ |
| Contact name | Dr Donna Greenhalgh |
| Contact details | Consultant Anaesthetist
Wythenshawe Hospital
South Moore Road
Wythenshawe
Manchester
United Kingdom
M23 9LT |
| Contact telephone | +44 (0)161 291 2525 |
| Contact email | donna.greenhalgh@btopenworld.com |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN71629284 |
| Date last extracted from ISRCTN register | 17/04/2008 |
