Status:
TERMINATED
Sodium Bicarbonate in Cardiac Surgery Study
Lead Sponsor:
Austin Health
Conditions:
Cardiac Surgery
Cardiopulmonary Bypass
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
With over one million operations a year, cardiac surgery with cardiopulmonary bypass is one of the most common major surgical procedures worldwide (1). Acute kidney injury is a common and serious post...
Detailed Description
Renal impairment following cardiopulmonary bypass is common. While most of these patients do not require either short or long term renal replacement, the mortality of patients with acute renal failure...
Eligibility Criteria
Inclusion
- Cardiac surgical patients in whom the use of cardiopulmonary bypass was planned and:
- Written informed consent of patient
- Age \>18 years
- And having at least one ore more of the following risk factors for postoperative AKI:
- Age =/\>70 years
- Preoperative plasma creatinine \>120 µmol/L New York Heart Association class III / IV or LVEF \<35%
- Insulin dependent diabetes mellitus
- Valve surgery (with or without coronary artery bypass graft)
- Redo cardiac surgery
Exclusion
- Cardiac surgical patients will not be considered eligible if:
- An emergency operation is indicated (within 24 hours after hospital admission or on intra-aortic balloon pump) or
- Pregnancy is confirmed or breastfeeding is present or
- A renal allograft is present or
- Preoperative acute renal failure within 6 weeks (acute rise in serum creatinine \>50% from baseline) is present or
- Pre-operative end stage renal disease (serum creatinine \>300 µmol/L) is present or
- Chronic moderate to high dose corticosteroid therapy (\>10 mg/d prednisone or equivalent) is present
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT00672334
Start Date
May 1 2008
End Date
January 1 2012
Last Update
August 1 2012
Active Locations (4)
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1
Austin Health
Melbourne, Victoria, Australia, 3084
2
University of Alberta
Edmonton, Alberta, Canada, T6G 2B7
3
Charité University Medicine
Berlin, State of Berlin, Germany, 13353
4
University Clinic Dublin, School of Medicine and Medical Science
Dublin, Dublin, Ireland