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

NCT ID: NCT00494637

Last Updated: 2009-01-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 468 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2009-01-31

Brief Summary

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.

Conditions

Contrast Induced Nephropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Interventions

sodium bicarbonate

isotonic sodium bicarbonate at 3 cc/kg for one hour followed by 2 cc kg/hr for 4 hours

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• serum creatinine greater then or equal to 1.5

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GE Healthcare

INDUSTRY

Sponsor Role: collaborator

Lenox Hill Hospital

OTHER

Sponsor Role: lead

Responsible Party

Lenox Hill Hospital

Principal Investigators

Jordan L Rosenstock, MD

Role: PRINCIPAL_INVESTIGATOR

Lenox Hill Hospital

Other Identifiers

L06.10.058

Identifier Type: -

Identifier Source: org_study_id