Preventing Acute Renal Failure After Cardiac Surgery in High Risk Patients Using Sodium Bicarbonate Therapy

NCT00522756 | Unknown Phase 3

• 1 other identifier: SDR-05-045
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  3 days

Secondary Outcomes (1)

• Postoperative vasoactive medication, intra-aortic balloon pump, mechanical ventilation, reintubation, reoperation, myocardial infarction, stroke, infection, hypokalemia, dialysis, ICU and hospital length of stay and survival.

  3 weeks post operative period

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Drug: Sodium bicarbonate

Control

ACTIVE COMPARATOR

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.

Drug: Sodium chloride

Interventions

Sodium bicarbonate DRUG

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.

Also known as: NaHCO3

Intervention

Sodium chloride DRUG

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.

Also known as: saline

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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%

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (1)

McGill University Health Centre - Royal Victoria Hospital

Montreal, Quebec, H3A1A1, Canada

RECRUITING

Related Publications (1)

• Merten GJ, Burgess WP, Gray LV, Holleman JH, Roush TS, Kowalchuk GJ, Bersin RM, Van Moore A, Simonton CA 3rd, Rittase RA, Norton HJ, Kennedy TP. Prevention of contrast-induced nephropathy with sodium bicarbonate: a randomized controlled trial. JAMA. 2004 May 19;291(19):2328-34. doi: 10.1001/jama.291.19.2328.

  PMID: 15150204 BACKGROUND

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Sodium Bicarbonate; Sodium Chloride

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Bicarbonates; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Sodium Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds

Study Officials

• Benoit de Varennes, MD

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

  PRINCIPAL INVESTIGATOR

• Ahsan Alam, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carole Albert, RN

CONTACT

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

Ahsan Alam, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2007
• First Posted: August 30, 2007
• Study Start: May 1, 2006
• Primary Completion: December 1, 2012
• Study Completion: March 1, 2013
• Last Updated: October 24, 2012

Record last verified: 2012-10

Locations

CA (1)