The Effect of Sodium Bicarbonate on Postoperative Renal Function in Infective Endocarditis Patients Undergoing Open Heart Surgery
- Registration Number
- NCT01920126
- Lead Sponsor
- Yonsei University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Saline group Saline Saline group Sodium bicarbonate group sodium bicarbonate Sodium bicarbonate group
- Primary Outcome Measures
Name Time Method Comparison of the the peak creatinine level during the postoperative 48h by more than 0.3 mg/dL between two groups. 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
🇰🇷Seoul, Korea, Republic of