The Effect of Sodium Bicarbonate on Postoperative Renal Function in Infective Endocarditis Patients Undergoing Open Heart Surgery

Acute Kidney Injury Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01920126
• Other study ID #: 4-2013-0376
• Status: Completed
• Phase: Phase 4
• Start date: August 13, 2013
• Est. completion date: August 23, 2016

Study information

• Verified date: July 2018
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: August 23, 2016
• Est. primary completion date: August 23, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Endocarditis
• Endocarditis, Bacterial

Intervention

Drug:
• sodium 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
• Saline

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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