The Effect of Sodium Bicarbonate on Postoperative Renal Function in Infective Endocarditis Patients Undergoing Open Heart Surgery

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

PHASE4

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-13

Study Completion Date

2016-08-23

Brief Summary

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The purpose of study is to test whether perioperative sodium bicarbonate infusion can prevent acute kidney injury following open heart surgery in infective endocarditis patients.

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Detailed Description

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Conditions

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Acute Kidney Injury

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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Sodium bicarbonate group

Group Type EXPERIMENTAL

sodium bicarbonate

Intervention Type DRUG

0.5 mmol/kg for 1 hr, and then 0.15 mmol/kg/h for 23 hrs The infusion of study drug is started after anesthesia induction and continued until 24 hours after surgery

Saline group

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

Interventions

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sodium bicarbonate

0.5 mmol/kg for 1 hr, and then 0.15 mmol/kg/h for 23 hrs The infusion of study drug is started after anesthesia induction and continued until 24 hours after surgery

Intervention Type DRUG

Saline

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* adult patients over the age of 20 scheduled for open heart surgery for infective endocarditis

Exclusion Criteria

* end stage renal disease (serum creatinine concentration \> 300 μmol/L)
* on dialysis
* chronic moderate to high dose corticosteroid therapy (\> 10 mg/day prednisolon or equivalent)
* preoperative severe hypernatremia (Na+ \> 150 mmol/L), alkalemia (PH \> 7.50), or pulmonary edema
* neurocognitive dysfunction

Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No