Effect of Sodium Bicarbonate on Prevention of Acute Kidney Injury in High Risk Patients Undergoing Off-pump Coronary Artery Bypass (OPCAB)
Not Applicable
Completed
- Conditions
- Acute Kidney Injury
- Interventions
- Drug: normal saline
- Registration Number
- NCT01840241
- Lead Sponsor
- Yonsei University
- Brief Summary
In this single-site, randomized, controlled and double-blind clinical trial, the investigators evaluate the effect of sodium bicarbonate on prevention of acute kidney injury in high risk patients undergoing off pump coronary bypass surgery.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 162
Inclusion Criteria
- Patients older than 20 years
- scheduled for elective coronary artery bypass grafting.
- preoperative estimated glomerular filtration rate (eGFR) : 30 ~ 89 %
- LVEF < 35%
- NYHA class III or IV
- age > 70
- DM
- reoperation
Exclusion Criteria
- acute renal impairment
- patients who receive dialysis
- patients who receive steroid ( > 10mg/day prednisolon or equivalent)
- hemo-alkalosis
- hypernatremia
- pulmonary edema
- Hemoglobin < 10 mg/dL
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo group normal saline normal saline infusion BIVON group sodium bicarbonate -
- Primary Outcome Measures
Name Time Method compare the incidence of acute kidney injury Change of Indexes of renal function including SCr, cystatin C, creatinine clearance from 24 hrs before operation to postoperative day (POD) 5. The diagnostic criteria for AKI is followed by AKIN criteria (absolutely increase in the SCr concentration ≥ 0.3 mg/dL from baseline, ≥ 50% increase in the SCr concentration within 48 hours after operation).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Department of anesthesiology and pain medicine
🇰🇷Seoul, Korea, Republic of