Does N-Acetylcysteine (Parvolex®) prophylaxis reduce the incidence of renal impairment after onpump Coronary Artery Bypass Graft surgery? A prospective randomised controlled trial
| ISRCTN | ISRCTN71629284 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN71629284 |
| Secondary identifying numbers | 07/Q1403/17 |
- Submission date
- 08/07/2007
- Registration date
- 21/08/2007
- Last edited
- 07/02/2012
- 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 Donna Greenhalgh
Scientific
Scientific
Consultant Anaesthetist
Wythenshawe Hospital
South Moore Road
Wythenshawe
Manchester
M23 9LT
United Kingdom
| Phone | +44 (0)161 291 2525 |
|---|---|
| donna.greenhalgh@btopenworld.com |
Study information
| Study design | Prospective randomised double blind controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study acronym | N-Acetylcysteine prophylaxis for onpump CABG |
| Study objectives | Prohylatic use of N-Acetylcysteine will decrease the incidence of renal failure in patients undergoing onpump Coronary Artery Bypass Graft (CABG) surgery. |
| Ethics approval(s) | Approved by South Manchester Research Ethics Committee (UK) on the 18th June 2007 (REC ref 07/Q1403/17). |
| Health condition(s) or problem(s) studied | Renal impairment |
| Intervention | 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. As of 07/02/2012, the trial was stopped in September 2010 due to problems with recruitment and the delay resulted in the trial being out of date. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | N-Acetylcysteine (Parvolex®) |
| Primary outcome measure | Creatinine clearance and serum creatinine levels on second and fifth post operative day and on discharge. |
| Secondary outcome measures | Length of Intensive Care Unit (ICU) stay. |
| Overall study start date | 01/08/2007 |
| Completion date | 31/07/2008 |
| Reason abandoned (if study stopped) | "Participant recruitment issue" |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 224 (112 in each group) (Trial stopped in September 2010) |
| Key inclusion criteria | 1. Patients undergoing elective coronoray artery bypass surgery (onpump) at Wythenshawe Hospital 2. Aged 21 - 80 years |
| Key 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 |
| Date of first enrolment | 01/08/2007 |
| Date of final enrolment | 31/07/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Consultant Anaesthetist
Manchester
M23 9LT
United Kingdom
M23 9LT
United Kingdom
Sponsor information
University Hospital of South Manchester NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Department of Research and Development
Wythenshawe Hospital
South Moore Road
Wythenshawe
Manchester
M23 9LT
England
United Kingdom
| Phone | +44 (0)161 291 5775 |
|---|---|
| andrew.maines@manchester.ac.uk | |
| Website | http://www.smuht.nwest.nhs.uk/ |
"ROR" |
https://ror.org/00he80998 |
Funders
Funder type
Government
University Hospital of South Manchester 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 |
