Recruiting
Phase 3

Sodium Bicarbonate

Sponsor:

McGill University Health Centre/Research Institute of the McGill University Health Centre

Code:

NCT00522756

Conditions

Kidney Failure, Acute

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Sodium bicarbonate

Sodium chloride

Study Details

Brief summary:

The purpose of this study is to determine whether sodium bicarbonate is effective in reducing kidney injury that may occur during cardiac surgery.

Conditions

Kidney Failure, Acute

Study ID

NCT00522756

Start date

May, 2006

Status verified date

Oct, 2012

Completion date

Mar, 2013

Anticipated

Primary completion date

Dec, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion criteria:

  • age greater than or equal to 18 years
  • elective or urgent CABG +/- valve surgery, or elective or urgent isolated valve surgery
  • exposure to cardiopulmonary bypass
  • stable kidney disease: less than 25% change in serum creatinine during 3 months before surgery
  • Estimated glomerular filtration rate, by Modification of Diet in Renal Disease (MDRD) equation, less than or equal to 60 ml/min/1.73m2

Exclusion criteria:

  • emergency CABG, cardiac transplantation, or insertion of VAD
  • planned off-pump surgery
  • N-acetylcysteine given in last 72 hours prior to operation
  • radiocontrast given in last 48 hours prior to operation
  • acute renal failure (greater than 25% increase in serum creatinine from preadmission baseline)
  • glomerular filtration rate less than 15 ml/min or chronic dialysis
  • prior renal transplantation
  • enrollment in another research study, with the exception of MUHC study SDR-05-033
  • LV ejection fraction less than or equal to 20%

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Intervention

Three ampoules of 7.5% sodium bicarbonate (89.3 mOsm/ampoule; total 150 ml for three ampoules) added to 750 ml of 5% dextrose in water, given at 1 ml/kg/hour through a dedicated intravenous line for 6 hours, and completed prior to the initiation of cardiopulmonary bypass.

active comparator: Control

0.9% sodium chloride given at 1 ml/kg/hour through a dedicated intravenous line for 6 hours, and completed prior to the initiation of cardiopulmonary bypass.

Interventions

Sodium bicarbonate

Three ampoules of 7.5% sodium bicarbonate (89.3 mOsm/ampoule; total 150 ml for three ampoules) added to 750 ml of 5% dextrose in water, given at 1 ml/kg/hour through a dedicated intravenous line for 6 hours, and completed prior to the initiation of cardiopulmonary bypass.

Sodium chloride

0.9% sodium chloride given at 1 ml/kg/hour through a dedicated intravenous line for 6 hours, and completed prior to the initiation of cardiopulmonary bypass.

Primary outcome measure

  • Increase in serum creatinine of 44 micromol/L or by 25% within the first 3 days after surgery. [ Time Frame: 3 days ]

Central Contacts and Locations

Central contacts

Carole Albert, RN

(514) 934-1934carole.albert@muhc.mcgill.ca

Ahsan Alam, MD

(514) 934-1934ahsan.alam@mcgill.ca

Locations

McGill University Health Centre - Royal Victoria Hospital

Recruiting

Montreal, Quebec, Canada, H3A1A1

Principal Investigator:

Benoit de Varennes, MD

More Information

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Last update posted

Oct 24, 2012

Last verified

Oct, 2012

Keywords

  • Kidney Failure, Acute
  • Cardiac Surgical Procedures
  • Sodium Bicarbonate
  • Sodium Chloride
  • Prevention and control

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by McGill University Health Centre/Research Institute of the McGill University Health Centre on 2012-10-24.