Condition category
Surgery
Date applied
03/11/2009
Date assigned
27/11/2009
Last edited
27/11/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Publication citations

Additional files

Editorial Notes