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

Phase 4CompletedNCT01920126

Yonsei University70 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

Conditions

Acute Kidney Injury

Interventions

sodium bicarbonateDRUG

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

SalineDRUG

Eligibility

Sex: ALLMin age: 20 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine

Seoul, South Korea

Outcomes

Primary Outcomes

Comparison of the the peak creatinine level during the postoperative 48h by more than 0.3 mg/dL between two groups.

We would investigate if the peak creatinine level during the postoperative 48h would differ by more than 0.3 mg/dL between two groups. The primary outcome was decided based on the AKIN criteria which defines acute kidney injury if serum creatinine increases more than 0.3 mg/dL during the postoperative 48 h. ; increase in serum creatinine of 0.3 mg/dL or \>50 percent developing over \<48 hours

Time frame: postoperative 48 hours

Data from ClinicalTrials.gov

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