The Effect of Sodium Bicarbonate on Postoperative Renal Function in Infective Endocarditis Patients Undergoing Open Heart Surgery
1 other identifier
interventional
70
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Aug 2013
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 31, 2013
CompletedFirst Posted
Study publicly available on registry
August 9, 2013
CompletedStudy Start
First participant enrolled
August 13, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 23, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 23, 2016
CompletedJuly 17, 2018
July 1, 2018
3 years
July 31, 2013
July 15, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
postoperative 48 hours
Study Arms (2)
Sodium bicarbonate group
EXPERIMENTALSodium bicarbonate group
Saline group
PLACEBO COMPARATORSaline group
Interventions
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
Eligibility Criteria
You may qualify if:
- adult patients over the age of 20 scheduled for open heart surgery for infective endocarditis
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Seoul, 120-752, South Korea
Related Publications (1)
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.
PMID: 28057030DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 31, 2013
First Posted
August 9, 2013
Study Start
August 13, 2013
Primary Completion
August 23, 2016
Study Completion
August 23, 2016
Last Updated
July 17, 2018
Record last verified: 2018-07