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

Yonsei University

Status and phase: Completed; Phase 4

Conditions: Acute Kidney Injury

Treatments: Drug: Saline; Drug: sodium bicarbonate

Study type: Interventional

Funder types: Other

Identifiers

NCT01920126

4-2013-0376

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: 20 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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70 participants in 2 patient groups, including a placebo group

Sodium bicarbonate group

Experimental group

Description:

Sodium bicarbonate group

Treatment:

Drug: sodium bicarbonate

Saline group

Placebo Comparator group

Description:

Saline group

Treatment:

Drug: Saline