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

Phase 4

Completed

• Conditions: Acute Kidney Injury
• Interventions: Drug: Saline; Drug: sodium bicarbonate

• 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

Study Timeline

• Study First Submitted: 2013-07-31
• Study First Submitted QC: 2013-08-06
• Study First Posted: 2013-08-09
• Study Start: 2013-08-13
• Primary Completion: 2016-08-23
• Study Completion: 2016-08-23
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-15
• Last Update Posted: 2018-07-17

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

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of