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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)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01840241
Enrollment
162
Registered
2013-04-25
Start date
2013-04-01
Completion date
2015-10-20
Last updated
2017-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury

Keywords

sodium bicarbonate, acute kidney injury, OPCAB

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.

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

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
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

* 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

Design outcomes

Primary

MeasureTime frameDescription
compare the incidence of acute kidney injuryChange 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).

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026