Sodium Bicarbonate in Cardiac Surgery

This study has been completed.
Sponsor:
Information provided by:
Austin Health
ClinicalTrials.gov Identifier:
NCT00334191
First received: June 5, 2006
Last updated: July 6, 2009
Last verified: July 2009
  Purpose

Many patients develop kidney failure after cardiac surgery. Although this kidney failure can usually be treated effectively, a longer stay in intensive care is often required. While many patients suffer no long term ill effects after developing post-operative kidney failure, some require long term kidney dialysis. We also know that patients who develop post-operative kidney failure are much more likely to die before they leave hospital.

Why some people develop kidney failure after cardiac surgery is not known. However, doctors suspect that the process of cardiopulmonary bypass (where the functions of the heart and lungs are taken over by a machine during the operation, to allow the surgeon to operate) overactivates some of the same mechanisms the body uses to defend itself against severe infection.

Many of the cell changes by which severe infection causes kidney failure also occur after cardiopulmonary bypass. One of the main overactive defence mechanisms is the release of highly toxic compounds derived from oxygen - a process called 'oxidative stress'.

The investigators believe that sodium bicarbonate might reduce the oxidative stress, which occurs during cardiac surgery, and so prevent or decrease the kidney failure, which occurs in many patients.

The investigators hope to give sodium bicarbonate (in similar doses to those used safely for treatment of acidosis) to patients during, and for 24 hours after cardiac surgery, and to compare the effects with patients who have not had sodium bicarbonate. The drug, or a placebo, will be given through the drip, which is present in all cardiac surgery patients. Whether a particular patient receives the drug or placebo will be decided at random, and neither the patient nor the investigators will know which has been given. We will measure kidney function before and after the operation using the standard blood tests.

The investigators will also take four 20ml samples of blood, spaced before, during, and after the operation, from the arterial catheter routinely inserted in every patient. This blood would be used to measure oxidative stress, and also some of the proteins inside the blood cells, which are responsible for creating the toxic oxygen compounds. In this way we will discover not only the effect of sodium bicarbonate, but also the mechanism of that effect.

Sodium bicarbonate is commonly used to treat metabolic acidosis in severe renal disease, circulatory insufficiency due to shock or severe dehydration and has been shown to be an effective drug in preventing contrast-induced nephropathy.

Sodium bicarbonate is considered to be safe in the setting of intensive care treatment and is often used in the treatment of patients with metabolic acidosis without any discernible adverse clinical effects.

This is a pilot study. If the drug proves effective in this context, further studies on a larger scale would be required to justify its general use.

There will be no extra risk to a patient who participates in the study, and no discomfort other than that normally associated with cardiac surgery.

Informed consent will be obtained from the patient prior to the operation by one of the investigators or the ICU research nurse. The clinical care of a patient who does not consent for any reason will not be affected.


Condition Intervention Phase
Cardiac Surgery and Cardiopulmonary Bypass
Drug: Sodium Bicarbonate
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: A Randomised, Double Blind, Placebo Controlled Pilot Study of the Effect of Sodium Bicarbonate on Postoperative Renal Function and Oxidative Stress in Patients Undergoing Elective Cardiopulmonary Bypass.

Resource links provided by NLM:


Further study details as provided by Austin Health:

Primary Outcome Measures:
  • Proportion of patients developing an increase in serum creatinine greater than 25% from baseline to peak level within first five postoperative days.

Secondary Outcome Measures:
  • Proportion of patients developing an increase in serum creatinine greater than 50% from baseline to peak level within first five postoperative days.
  • Relative change in serum creatinine,
  • Urinary output,
  • Use of renal replacement therapy (RRT),
  • Acute renal dysfunction,
  • Duration of ventilation,
  • Chest tube drainage,
  • Need for return to operating room,
  • Incidence of post-operative atrial fibrillation (AF),
  • Duration of stay in the intensive care unit (ICU)
  • Duration of stay in hospital

Estimated Enrollment: 100
Study Start Date: June 2006
Estimated Study Completion Date: June 2006
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age above 70 years
  • Preexisting renal impairment (preoperative serum creatinine level >120µmol/L
  • New York Heart Association class III/IV or Moderate to poor left ventricular dysfunction
  • Valve surgery or complex cardiac surgery
  • Redo cardiac surgery
  • Insulin-dependent diabetes mellitus

Exclusion Criteria:

  • Age <18 years
  • Emergency cardiac surgery
  • Planned off-pump cardiac surgery
  • Enrolled in conflicting research study
  • Known blood-borne infectious disease
  • Chronic inflammatory disease on immunosuppression
  • Chronic moderate to high dose corticosteroid therapy (>10mg/d prednisone or equivalent)
  • End stage renal disease (serum creatinine >300µmol/L)
  • Thiamine deficiency will be excluded on medical and dietary history.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00334191

Locations
Australia, Victoria
Austin Hospital
Melbourne, Victoria, Australia, 3084
Sponsors and Collaborators
Austin Health
Investigators
Principal Investigator: Rinaldo Bellomo, MD, FRACP Austin Health
  More Information

No publications provided by Austin Health

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00334191     History of Changes
Other Study ID Numbers: H2005/02249
Study First Received: June 5, 2006
Last Updated: July 6, 2009
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Austin Health:
Cardiac surgery,
Cardiopulmonary bypass,
Oxidative stress,
Acute renal dysfunction,
Sodium Bicarbonate

ClinicalTrials.gov processed this record on October 19, 2014