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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2013 by Yonsei University.
Recruitment status was  Recruiting
Information provided by (Responsible Party):
Yonsei University Identifier:
First received: July 31, 2013
Last updated: February 24, 2014
Last verified: August 2013
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.

Condition Intervention Phase
Acute Kidney Injury
Drug: sodium bicarbonate
Drug: Saline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention

Resource links provided by NLM:

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • Comparison of the incidence of postoperative acute kidney injury in patients with or without sodium bicarbonate [ Time Frame: postoperative 48 hours ] [ Designated as safety issue: No ]

    acute kidney injury based on the AKIN criteria

    ; increase in serum creatinine of 0.3 mg/dL or >50 percent developing over <48 hours

Estimated Enrollment: 70
Study Start Date: August 2013
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sodium bicarbonate group
Sodium bicarbonate group
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
Placebo Comparator: Saline group
Saline group
Drug: Saline


Ages Eligible for Study:   20 Years to 90 Years
Genders Eligible for Study:   Both
Accepts 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01920126

Contact: Jong Wook Song, MD 2-2-2228-2420

Korea, Republic of
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Jong Wook Song, MD    82-2-2228-2420   
Sponsors and Collaborators
Yonsei University
  More Information

Responsible Party: Yonsei University Identifier: NCT01920126     History of Changes
Other Study ID Numbers: 4-2013-0376 
Study First Received: July 31, 2013
Last Updated: February 24, 2014
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Yonsei University:
sodium bicarbonate, renal function, infective endocarditis, open heart surgery

Additional relevant MeSH terms:
Endocarditis, Bacterial
Acute Kidney Injury
Bacterial Infections
Cardiovascular Diseases
Cardiovascular Infections
Heart Diseases
Kidney Diseases
Renal Insufficiency
Urologic Diseases processed this record on May 26, 2016