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

NCT ID: NCT01840241

Last Updated: 2017-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

162 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-01

Study Completion Date

2015-10-20

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Kidney Injury

Keywords

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sodium bicarbonate acute kidney injury OPCAB

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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BIVON group

Group Type EXPERIMENTAL

sodium bicarbonate

Intervention Type 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.

Placebo group

normal saline infusion

Group Type PLACEBO_COMPARATOR

normal saline

Intervention Type DRUG

Interventions

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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.

Intervention Type DRUG

normal saline

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of anesthesiology and pain medicine

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 28077531 (View on PubMed)

Other Identifiers

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4-2012-0419

Identifier Type: -

Identifier Source: org_study_id