The Use of Sodium Bicarbonate in the Prevention of Contrast Induced Nephropathy

Lenox Hill Hospital

Status: Terminated

Conditions: Contrast Induced Nephropathy

Treatments: Drug: sodium bicarbonate

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00494637

L06.10.058

Details and patient eligibility

About

Preliminary studies have shown a benefit of sodium bicarbonate infusion in decreasing the risk of contrast induced nephropathy with coronary angiography. The investigators plan to randomize 478 patients (with serum creatinine 1.5 mg/dl or greater) undergoing coronary angiography to intravenous isotonic saline or intravenous isotonic sodium bicarbonate beginning one hour before the procedure and for four hours after. The primary endpoint is the development of contrast nephropathy within 48-72 hours after the procedure. Patients with an ejection fraction <30%, overt CHF, hypokalemia and alkalemia will be excluded.

Enrollment: 468 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• serum creatinine greater then or equal to 1.5

Exclusion criteria

• EF<30
• Overt CHF
• Alkalemia
• Hypokalemia
• GFR<20 cc/min

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind