Prevention of kidney failure using N-acetylcystein and sodium bicarbonate in patients undergoing aortic aneurysm repair.
| ISRCTN | ISRCTN39325111 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN39325111 |
| Secondary identifying numbers | CHUM 08.110 |
- Submission date
- 03/11/2009
- Registration date
- 27/11/2009
- Last edited
- 27/11/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
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 Pierre Beaulieu
Scientific
Scientific
3840 rue St-Urbain
Montreal
H2W1T8
Canada
| pierre.beaulieu@umontreal.ca |
Study information
| Study design | Prospective randomised double blind placebo controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Impact of N-acetylcystein and sodium bicarbonate administration on the prevention of contrast media-induced nephropathy in endovascular aortic aneurysm repair. A prospective, randomised, placebo-controlled trial. |
| Study acronym | NACASRI |
| Study objectives | The hypothesis underlying this trial is that perioperative intravenous hydration with sodium bicarbonate with perioperative administration of N-Acetylcystein can reduce the incidence of post operative renal failure by 30%, by reducing the incidence of contrast media-induced nephropathy. |
| Ethics approval(s) | Approved by the Research Ethics Committee of CHUM (Comité d'éthique de la recherche du Centre Hospitalier de l'Université de Montréal [CHUM]), Canada on December 18th 2008 (ref: 08.110) |
| Health condition(s) or problem(s) studied | Aortic surgery. Renal failure. |
| Intervention | Patients will be randomly allocated, according to a computer-generated list, to one of two groups: A. Group NB (N-acetylcystein plus sodium bicarbonate) B. Group S (N-acetylcystein plus Saline). 1. Fifteen minutes before the induction of general anaesthesia, on the day of the surgery, patients in both groups will receive 150 mg/kg IV N-Acetylcystein diluted in 500 ml of normal saline. 2. N-Acetylcystein 1200 mg PO will be given again at 9:00 PM the evening of the surgery and will be given twice (BID) for the first post operative day. It will then be discontinued. 3. Also, one hour prior to the injection of contrast media, which means at the time of induction of general anesthesia, patients in group NS will receive an infusion of sodium bicarbonates (154 MEq/L sodium bicarbonates diluted in 1L of Dextrose 5% in water) at the rate of 3 ml/kg/h, for one hour. This infusion will be continued in these patients at the rate of 1 ml/kg/h for the entire duration of the surgery, until 6 hours post operatively, after which it will be stopped. Patients in group S will receive, at the same infusion rate, a placebo (normal saline). |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 1. the incidence of post operative renal failure; 2. the incidence of post operative renal failure requiring dialysis in the first 30 days following surgery; |
| Secondary outcome measures | The 30-day mortality of patients who had such a surgery. |
| Overall study start date | 01/01/2009 |
| Completion date | 01/01/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | We will collect data from 60 patients in two years. |
| Key inclusion criteria | 1. Patients between 18 and 85 years old. 2. Patients undergoing an elective endovascular aortic repair surgery. 3. ASA I-IV inclusively (ASA: American Society of Anesthesiologists). |
| Key exclusion criteria | 1. Patient refusal. 2. Patients who were exposed to contrast media in the last 14 days. 3. Patients presenting with acute renal failure on the day of surgery, as indicated by an increase of 25% or more in serum creatinine from baseline values. 4. History of kidney transplant. 5. Patients with terminal renal failure, treated with dialysis. |
| Date of first enrolment | 01/01/2009 |
| Date of final enrolment | 01/01/2011 |
Locations
Countries of recruitment
- Canada
Study participating centre
3840 rue St-Urbain
Montreal
H2W1T8
Canada
H2W1T8
Canada
Sponsor information
University of Montreal Hospital Centre (Centre hospitalier de l'Université de Montréal [CHUM]) (Canada)
Hospital/treatment centre
Hospital/treatment centre
3840 rue St-Urbain
Montreal
H2W1T8
Canada
| pierre.beaulieu@umontreal.ca | |
"ROR" |
https://ror.org/0410a8y51 |
Funders
Funder type
Hospital/treatment centre
University of Montreal Hospital Centre (Centre hospitalier de l'Université de Montréal [CHUM]) (Canada) - Dept of Pharmacology
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 |
