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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01920126
Recruitment Status : Recruiting
First Posted : August 9, 2013
Last Update Posted : June 21, 2016
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Acute Kidney Injury Drug: sodium bicarbonate Drug: Saline Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Study Start Date : August 2013
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endocarditis
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Comparison of the the peak creatinine level during the postoperative 48h by more than 0.3 mg/dL between two groups. [ Time Frame: 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

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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Yonsei University Identifier: NCT01920126     History of Changes
Other Study ID Numbers: 4-2013-0376
First Posted: August 9, 2013    Key Record Dates
Last Update Posted: June 21, 2016
Last Verified: June 2016

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

Additional relevant MeSH terms:
Endocarditis, Bacterial
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Heart Diseases
Cardiovascular Diseases
Bacterial Infections
Cardiovascular Infections