Acute Kidney Injury
Conditions
Keywords
sodium bicarbonate, renal function, infective endocarditis, open heart surgery
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.
Interventions
DRUGsodium 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
DRUGSaline
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
South Korea
Outcome results
None listed