Effect of N-acetylcysteine on liver recovery after resection
| ISRCTN | ISRCTN01624686 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN01624686 |
| Secondary identifying numbers | N/A |
- Submission date
- 17/07/2014
- Registration date
- 13/08/2014
- Last edited
- 13/08/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
Background and study aims
Liver resection is surgical removal of a portion of the liver. It is the treatment for multiple cancerous and non-cancerous masses in the liver. After removing a part of the liver it has the ability to regenerate. In some laboratory and animal studies N-acetylcysteine, a medication commonly used in treatment of acetaminophen (a pain medicine) overdose, has shown the ability to improve liver regeneration after resection. This study will test this theory in humans.
Who can participate?
All adult patients who are undergoing a major resection of the liver.
What does the study involve?
Patients are randomly allocated to either receiving N-acetylcysteine after the liver resection or not receiving it. There are no other differences in the treatment.
What are the possible benefits and risks of participating?
The potential benefit is improved liver regeneration. Potential risks are side effects from receiving the medication.
Where is the study run from?
The Foothills Medical Center, Calgary, AB, Canada.
When is study starting and how long is it expected to run for?
The study ran from February 2007 until June 2012.
Who is funding the study?
Alberta Health Services (Canada).
Who is the main contact?
Dr Elijah Dixon
Elijah.Dixon@albertahealthservices.ca
Contact information
Scientific
Division of General Surgery
Faculty of Medicine
University of Calgary
EG - 26, Foothills Medical Centre
1403 - 29 Street NW
Calgary, AB
T2N2T9
Canada
| Phone | +1 (0) 403 944 3045 |
|---|---|
| elijah.dixon@albertaheathservices.ca |
Study information
| Study design | Randomized clinical trial, single institution, non-blinded |
|---|---|
| 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 | Effect of N-acetylcysteine on liver recovery after resection: a randomized clinical trial |
| Study objectives | The objective of this study is to determine whether N-acetylcysteine can reduce the incidence of postoperative liver dysfunction and the overall complication rate when administered following major hepatic resection (two or more Coinaud segments). |
| Ethics approval(s) | Conjoint Health Research Ethics Board, University of Calgary, 18/05/2010, ref. E18866 |
| Health condition(s) or problem(s) studied | Decrease in liver failure after liver resection for any diagnosis |
| Intervention | Both randomized groups will undergo the same preoperative and intraoperative management. The only difference in postoperative management will be use of N-acetylcysteine infusion - 150 mg/kg of NAC in 200 ml of 5% glucose over 45 minutes upon arrival in the post-anaesthesia recovery room. Then 50 mg/kg of NAC in 500 ml of 5% glucose over 4 hours, followed by 100 mg/kg in 1000 ml of 5% glucose over the next 16 hours, followed by 100 mg/kg in 1000 ml of 5% glucose per day over the next 3 days, which will be administered in six infusions of 50 mg/kg in 500 ml of 5% glucose, given over 12 hours each (intervention group only) |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | N-acetylcysteine |
| Primary outcome measure | Overall complication rate. These will be recorded in a prospective fashion throughout the trial. Coding will then be done according to the Clavien-Dindo classification, which is the most common description of types of complications (grade I, II, IIIa, IIIb, IVa, IVb and V). |
| Secondary outcome measures | Postoperative liver failure as defined by: 1. The 50-50 criterion (PT>50% (INR>1.7), bilirubin > 50 umol/l (3 mg/dL) on postoperative day 5) 2. Length of stay 3. Postoperative mortality |
| Overall study start date | 01/02/2007 |
| Completion date | 01/06/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 460 |
| Key inclusion criteria | All adult patients scheduled to undergo major hepatic resection (defined as the removal of at least two Couinaud segments) for any cause at the Foothills Medical Centre who give written informed consent are eligible for the study. |
| Key exclusion criteria | Participation in other trials before or during treatment |
| Date of first enrolment | 01/02/2007 |
| Date of final enrolment | 01/06/2012 |
Locations
Countries of recruitment
- Canada
Study participating centre
T2N2T9
Canada
Sponsor information
Hospital/treatment centre
10101 Southport Rd SW
Calgary, AB
T2W3N2
Canada
"ROR" |
https://ror.org/02nt5es71 |
|---|
Funders
Funder type
Hospital/treatment centre
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 |
