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

Yonsei University1 site in 1 country162 target enrollmentApril 1, 2013

ConditionsAcute Kidney Injury

Interventionssodium bicarbonate normal saline

Drugssodium bicarbonate normal saline

Overview

Phase: Not Applicable
Intervention: sodium bicarbonate
Conditions: Acute Kidney Injury
Sponsor: Yonsei University
Enrollment: 162
Locations: 1
Primary Endpoint: compare the incidence of acute kidney injury
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 1, 2013

End Date

October 20, 2015

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Yonsei University

Responsible Party

Sponsor

Eligibility Criteria

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
•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

Arms & Interventions

BIVON group

Intervention: sodium bicarbonate

Placebo group

normal saline infusion

Intervention: normal saline

Outcomes

Primary Outcomes

compare the incidence of acute kidney injury

Time Frame: 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).