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

Primary Purpose

Acute Kidney Injury

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
sodium bicarbonate
normal saline
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Kidney Injury focused on measuring sodium bicarbonate, acute kidney injury, OPCAB

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Department of anesthesiology and pain medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

BIVON group

Placebo group

Arm Description

normal saline infusion

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
April 17, 2013
Last Updated
October 25, 2017
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT01840241
Brief Title
Effect of Sodium Bicarbonate on Prevention of Acute Kidney Injury in High Risk Patients Undergoing Off-pump Coronary Artery Bypass (OPCAB)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
April 1, 2013 (Actual)
Primary Completion Date
October 20, 2015 (Actual)
Study Completion Date
October 20, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury
Keywords
sodium bicarbonate, acute kidney injury, OPCAB

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
162 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BIVON group
Arm Type
Experimental
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
normal saline infusion
Intervention Type
Drug
Intervention Name(s)
sodium bicarbonate
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
normal saline
Primary Outcome Measure Information:
Title
compare the incidence of acute kidney injury
Description
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).
Time Frame
Change of Indexes of renal function including SCr, cystatin C, creatinine clearance from 24 hrs before operation to postoperative day (POD) 5.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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 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
Facility Information:
Facility Name
Department of anesthesiology and pain medicine
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
28077531
Citation
Soh S, Song JW, Shim JK, Kim JH, Kwak YL. Sodium bicarbonate does not prevent postoperative acute kidney injury after off-pump coronary revascularization: a double-blinded randomized controlled trial. Br J Anaesth. 2016 Oct;117(4):450-457. doi: 10.1093/bja/aew256. Epub 2016 Oct 17.
Results Reference
derived

Learn more about this trial

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

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