Use of Bicarbonate to Reduce the Incidence of Acute Renal Failure After Cardiac Surgery
Completed · Phase 2 · Has a placebo group
Conditions studied: Kidney Failure, Acute, Renal Replacement Therapy
In brief
The purpose of this study is to determine if the incidence of acute renal failure (ARF) in high risk patients who undergo coronary artery bypass grafting (CABG) is reduced by treating patients in the perioperative period with intravenous (IV) sodium bicarbonate. Patients will be randomized in a 50:50 allocation to receive either IV sodium bicarbonate or IV normal saline. The volume of fluid given in each arm of the study is equal. All other interventions in those patients will be according to standard cardiothoracic anesthesia protocol at our institution.
Key facts
- Study ID
- NCT00484354
- Run by
- Wake Forest University Health Sciences
- People needed
- 123
- Starts
- 2006-05-01
- Expected to finish
- 2013-12-01
- Last updated by the study team
- 2018-10-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Calculated GFR ≤ 60 ml/min/m2 (MDRD)
- OR
- Any combination of two (2) of the following:
- Age ≥ 70
- Complex surgery (any of the following):
- CABG/Valve
- Redo operation
- Deep hypothermic arrest
- ≥ 2 valves
- History of PVD surgery
- EF < 35%
- Presence of diabetes mellitus
- Prior kidney transplant
You may not qualify if…
- Age < 18
- Pre-existing ESRD (dialysis patients)
- Pre-op GFR ≤ 15 ml/min/m2
- Pre-op bicarbonate level ≥ 30 mEq/L
- Emergency surgery (unable to effectively consent)
- Pregnancy
- Heart transplant (OHT)
- Aortic surgery (proximal or distal)
Where it is running
- Wake Forest University School of Medicine — Winston-Salem, North Carolina, United States
Full record on ClinicalTrials.gov
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