Effect of Sodium Bicarbonate on Prevention of Acute Kidney Injury in High Risk Patients Undergoing Off-pump Coronary Artery Bypass (OPCAB)
1 other identifier
interventional
162
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2013
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2013
CompletedFirst Submitted
Initial submission to the registry
April 17, 2013
CompletedFirst Posted
Study publicly available on registry
April 25, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 20, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 20, 2015
CompletedOctober 27, 2017
October 1, 2017
2.6 years
April 17, 2013
October 25, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Study Arms (2)
BIVON group
EXPERIMENTALPlacebo group
PLACEBO COMPARATORnormal saline infusion
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of anesthesiology and pain medicine
Seoul, 120-752, South Korea
Related Publications (1)
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.
PMID: 28077531DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 17, 2013
First Posted
April 25, 2013
Study Start
April 1, 2013
Primary Completion
October 20, 2015
Study Completion
October 20, 2015
Last Updated
October 27, 2017
Record last verified: 2017-10