Contact information
Type
Scientific
Primary contact
Dr Pierre Beaulieu
ORCID ID
Contact details
3840 rue St-Urbain
Montreal
H2W1T8
Canada
pierre.beaulieu@umontreal.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
CHUM 08.110
Study information
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.
Acronym
NACASRI
Study hypothesis
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
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)
Study design
Prospective randomised double blind placebo controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
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 trial start date
01/01/2009
Overall trial end date
01/01/2011
Reason abandoned
Eligibility
Participant 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).
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
We will collect data from 60 patients in two years.
Participant 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.
Recruitment start date
01/01/2009
Recruitment end date
01/01/2011
Locations
Countries of recruitment
Canada
Trial participating centre
3840 rue St-Urbain
Montreal
H2W1T8
Canada
Sponsor information
Organisation
University of Montreal Hospital Centre (Centre hospitalier de l'Université de Montréal [CHUM]) (Canada)
Sponsor details
3840 rue St-Urbain
Montreal
H2W1T8
Canada
pierre.beaulieu@umontreal.ca
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
University of Montreal Hospital Centre (Centre hospitalier de l'Université de Montréal [CHUM]) (Canada) - Dept of Pharmacology
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary