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

Sponsor

Yonsei University (Other)

Overall Status

Completed

CT.gov ID

NCT01840241

Collaborator

(none)

162

Enrollment

Location

Arms

30.6

Actual Duration (Months)

5.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Kidney Injury	Drug: sodium bicarbonate Drug: normal saline	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

162 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Prevention

Actual Study Start Date :

Apr 1, 2013

Actual Primary Completion Date :

Oct 20, 2015

Actual Study Completion Date :

Oct 20, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BIVON group	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.
Placebo Comparator: Placebo group normal saline infusion	Drug: normal saline

Arm

Intervention/Treatment

Experimental: BIVON group

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.

Placebo Comparator: Placebo group

normal saline infusion

Drug: normal saline

Outcome Measures

Primary Outcome Measures

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of anesthesiology and pain medicine	Seoul		Korea, Republic of	120-752

Sponsors and Collaborators

Yonsei University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yonsei University

ClinicalTrials.gov Identifier:

NCT01840241

Other Study ID Numbers:

4-2012-0419

First Posted:

Apr 25, 2013

Last Update Posted:

Oct 27, 2017

Last Verified:

Oct 1, 2017

Keywords provided by Yonsei University

sodium bicarbonate

acute kidney injury

OPCAB

Additional relevant MeSH terms:

Acute Kidney Injury

Study Results

No Results Posted as of Oct 27, 2017