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OpenTrials
Completed

NCT Number: NCT01840241

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

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.

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Key information

Conditions

Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of anesthesiology and pain medicine

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sodium bicarbonate

Drug

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.

normal saline

Drug

Primary outcomes

  1. compare the incidence of acute kidney injury

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Apr 25, 2013
Registry last updated
Oct 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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