Effect of Sodium Bicarbonate on Prevention of Acute Kidney Injury in High Risk Patients Undergoing Off-pump Coronary Artery Bypass (OPCAB)

Yonsei University

Status: Completed

Conditions: Acute Kidney Injury

Treatments: Drug: sodium bicarbonate; Drug: normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT01840241

4-2012-0419

Details and patient eligibility

About

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.

Enrollment: 162 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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162 participants in 2 patient groups, including a placebo group

BIVON group

Experimental group

Treatment:

Drug: sodium bicarbonate

Placebo group

Placebo Comparator group

Description:

normal saline infusion

Treatment:

Drug: normal saline