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

This study is currently recruiting participants.
Verified August 2013 by Yonsei University
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01920126
First received: July 31, 2013
Last updated: February 24, 2014
Last verified: August 2013
  Purpose

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

  Eligibility

Ages Eligible for Study:   20 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01920126

Contacts
Contact: Jong Wook Song, MD 2-2-2228-2420 SJW72331@yuhs.ac

Locations
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    SJW72331@yuhs.ac   
Sponsors and Collaborators
Yonsei University
  More Information

No publications provided

Responsible Party: Yonsei University
ClinicalTrials.gov 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
Endocarditis, Bacterial
Acute Kidney Injury
Wounds and Injuries
Heart Diseases
Cardiovascular Diseases
Bacterial Infections
Cardiovascular Infections
Infection
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on April 16, 2014