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CompletedNCT01840241Updated Oct 27, 2017

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

An interventional study of sodium bicarbonate and normal saline in Acute Kidney Injury, sponsored by Yonsei University. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2017-10-27.

Sponsored by Yonsei University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
162
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Acute Kidney Injury

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Keywords

  • sodium bicarbonate
  • acute kidney injury
  • OPCAB
03

In context

Acute Kidney Injury

1,595 studies on the registry are indexed under Acute Kidney Injury; 371 are open to participants now.

This study's enrollment of 162 is above the median of 100 across 763 interventional studies indexed under Acute Kidney Injury.

Browse Acute Kidney Injury studies →

Lead sponsor

Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
162 participants (actual)

Study arms

  • Experimental
    BIVON group

    Drug: sodium bicarbonate

  • Placebo comparator
    Placebo group

    normal saline infusion

    Drug: normal saline

Interventions

  • Drugsodium 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.

  • Drugnormal saline
06

What researchers measure

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).

    Time frame: Change of Indexes of renal function including SCr, cystatin C, creatinine clearance from 24 hrs before operation to postoperative day (POD) 5.

07

Study locations

1 site
  • Department of anesthesiology and pain medicine
    Seoul, 120-752, Korea, Republic of
08

References and documents

Publications

  • 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. PubMed 28077531 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 27, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01840241
Lead sponsor
Yonsei University
Responsible party
Sponsor
First posted
Apr 25, 2013
Start date
Apr 1, 2013
Primary completion
Oct 20, 2015
Completion
Oct 20, 2015
Last update
Oct 27, 2017

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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