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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)

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ClinicalTrials.gov Identifier: NCT01840241
Recruitment Status : Completed
First Posted : April 25, 2013
Last Update Posted : October 27, 2017
Sponsor:
Information provided by (Responsible Party):
Yonsei University

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.

Condition or disease Intervention/treatment Phase
Acute Kidney Injury Drug: sodium bicarbonate Drug: normal saline Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 162 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Actual Study Start Date : April 1, 2013
Actual Primary Completion Date : October 20, 2015
Actual Study Completion Date : October 20, 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BIVON group Drug: sodium 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.

Placebo Comparator: Placebo group
normal saline infusion
Drug: normal saline



Primary Outcome Measures :
  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).



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01840241


Locations
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Korea, Republic of
Department of anesthesiology and pain medicine
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01840241     History of Changes
Other Study ID Numbers: 4-2012-0419
First Posted: April 25, 2013    Key Record Dates
Last Update Posted: October 27, 2017
Last Verified: October 2017
Keywords provided by Yonsei University:
sodium bicarbonate
acute kidney injury
OPCAB
Additional relevant MeSH terms:
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Acute Kidney Injury
Wounds and Injuries
Renal Insufficiency
Kidney Diseases
Urologic Diseases