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

Acute Kidney Injury Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01840241
• Other study ID #: 4-2012-0419
• Status: Completed
• Phase: N/A
• First received: April 17, 2013
• Last updated: October 25, 2017
• Start date: April 1, 2013
• Est. completion date: October 20, 2015

Study information

• Verified date: October 2017
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: October 20, 2015
• Est. primary completion date: October 20, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Wounds and Injuries

Intervention

Drug:
• sodium bicarbonate
BIVON group were received 0.5 mmol/kg of sodium bicarbonate for 1hours after induction of anesthesia and following 0.15 mmol/kg of sodium bicarbonate during the operation.
• normal saline

Locations

Country	Name	City	State
Korea, Republic of	Department of anesthesiology and pain medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	compare the incidence of acute kidney injury	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).	Change of Indexes of renal function including SCr, cystatin C, creatinine clearance from 24 hrs before operation to postoperative day (POD) 5.