Status:
TERMINATED
Bicarbonate in Cardiac Surgery
Lead Sponsor:
Austin Health
Conditions:
Acute Kidney Injury
Eligibility:
All Genders
70+ years
Phase:
PHASE2
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
- Age above 70 years
- Pre-existing renal impairment (preoperative plasma creatinine concentration \> 1.4 mg/dL
- New York Heart Association class III/IV or impaired left ventricular function (left ventricular ejection fraction \< 50%)
- Valvular surgery or concomitant valvular and coronary artery bypass graft surgery
- Redo cardiac surgery
- Insulin-dependent diabetes mellitus
Exclusion
- End stage renal disease (plasma creatinine concentration \> 3.4 mg/dL)
- Emergency cardiac surgery
- Planned off-pump cardiac surgery
- Known blood-borne infectious disease
- Chronic inflammatory disease on immunosuppression
- Chronic moderate to high dose corticosteroid therapy (\> 10 mg/d prednisone or equivalent)
- Enrolled in conflicting research study
- Age \< 18 years
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
427 Patients enrolled
Trial Details
Trial ID
NCT00878956
Start Date
April 1 2009
End Date
January 1 2012
Last Update
August 1 2012
Active Locations (4)
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1
Austin Hospital
Melbourne, Victoria, Australia, 3084
2
Warringal Private Hospital
Melbourne, Victoria, Australia, 3084
3
Auckland City Hospital
Auckland, New Zealand
4
Waikato Hospital
Hamilton, New Zealand