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

• Sponsor: Yonsei University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01920126
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Arms: 2
• Actual Duration (Months): 36.3
• Patients Per Site Per Month: 1.9

Study Details

Study Description

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 Design

• Study Type: Interventional
• Actual Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Prevention
• Actual Study Start Date: Aug 13, 2013
• Actual Primary Completion Date: Aug 23, 2016
• Actual Study Completion Date: Aug 23, 2016

Arms and Interventions

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

Outcome Measures

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. [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 90 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine	Seoul		Korea, Republic of	120-752

Sponsors and Collaborators

• Yonsei University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yonsei University
• ClinicalTrials.gov Identifier: NCT01920126
• Other Study ID Numbers: 4-2013-0376
• First Posted: Aug 9, 2013
• Last Update Posted: Jul 17, 2018
• Last Verified: Jul 1, 2018

• Keywords provided by Yonsei University: sodium bicarbonate, renal function, infective endocarditis, open heart surgery
• Additional relevant MeSH terms: Acute Kidney Injury; Endocarditis

Study Results

No Results Posted as of Jul 17, 2018