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Clinical Trials/NCT01920126
NCT01920126
Completed
Phase 4

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

Yonsei University1 site in 1 country70 target enrollmentAugust 13, 2013

Overview

Phase
Phase 4
Intervention
sodium bicarbonate
Conditions
Acute Kidney Injury
Sponsor
Yonsei University
Enrollment
70
Locations
1
Primary Endpoint
Comparison of the the peak creatinine level during the postoperative 48h by more than 0.3 mg/dL between two groups.
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
August 13, 2013
End Date
August 23, 2016
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Arms & Interventions

Sodium bicarbonate group

Sodium bicarbonate group

Intervention: sodium bicarbonate

Saline group

Saline group

Intervention: Saline

Outcomes

Primary Outcomes

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

Time Frame: postoperative 48 hours

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

Study Sites (1)

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