Back to resultsThe Effect of Sodium Bicarbonate on Postoperative Renal Function in Infective Endocarditis Patients Undergoing Open Heart Surgery
Primary Purpose
Acute Kidney Injury
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
sodium bicarbonate
Saline
Sponsored by
About this trial
This is an interventional prevention trial for Acute Kidney Injury focused on measuring sodium bicarbonate, renal function, infective endocarditis, open heart surgery
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
Sites / Locations
- Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Sodium bicarbonate group
Saline group
Arm Description
Sodium bicarbonate group
Saline group
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01920126
Brief Title
The Effect of Sodium Bicarbonate on Postoperative Renal Function in Infective Endocarditis Patients Undergoing Open Heart Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
August 13, 2013 (Actual)
Primary Completion Date
August 23, 2016 (Actual)
Study Completion Date
August 23, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury
Keywords
sodium bicarbonate, renal function, infective endocarditis, open heart surgery
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sodium bicarbonate group
Arm Type
Experimental
Arm Description
Sodium bicarbonate group
Arm Title
Saline group
Arm Type
Placebo Comparator
Arm Description
Saline group
Intervention Type
Drug
Intervention Name(s)
sodium bicarbonate
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Saline
Primary Outcome Measure Information:
Title
Comparison of the the peak creatinine level during the postoperative 48h by more than 0.3 mg/dL between two groups.
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
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
Facility Information:
Facility Name
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
28057030
Citation
Cho JS, Soh S, Shim JK, Kang S, Choi H, Kwak YL. Effect of perioperative sodium bicarbonate administration on renal function following cardiac surgery for infective endocarditis: a randomized, placebo-controlled trial. Crit Care. 2017 Jan 5;21(1):3. doi: 10.1186/s13054-016-1591-z.
Results Reference
derived
Learn more about this trial
The Effect of Sodium Bicarbonate on Postoperative Renal Function in Infective Endocarditis Patients Undergoing Open Heart Surgery
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