TerminatedInterventionalPhase 2Phase 3Updated Aug 1, 2012
The Effect of Sodium Bicarbonate on Postoperative Renal Function in Infective Endocarditis Patients Undergoing Open Heart Surgery | NCT01920126 | Trialant
The Effect of Sodium Bicarbonate on Postoperative Renal Function in Infective Endocarditis Patients Undergoing Open Heart Surgery
ClinicalTrials.gov ID
NCT01920126
Lead Sponsor
Yonsei UniversityOTHER
Overall Status
Completed
Study Type
Interventional
Phase
Phase 4
Enrollment
70Actual
Last Update Posted
Jul 17, 2018Actual
Start Date
Aug 13, 2013Actual
Primary Completion Date
Aug 23, 2016Actual
Completion Date
Aug 23, 2016Actual
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.
Acute Kidney Injury
sodium bicarbonate
Saline
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
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
Primary Purpose
Prevention
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
Triple
No central contacts
There are no central contacts for this study.
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine