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

Contrast Induced Nephropathy Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00494637
• Other study ID #: L06.10.058
• Status: Terminated
• Phase: N/A
• First received: June 29, 2007
• Last updated: January 27, 2009
• Start date: July 2007
• Est. completion date: January 2009

Study information

• Verified date: January 2009
• Source: Lenox Hill Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 468
• Est. completion date: January 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• serum creatinine greater then or equal to 1.5

Exclusion Criteria:

• EF<30

• Overt CHF

• Alkalemia

• Hypokalemia

• GFR<20 cc/min

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Contrast Induced Nephropathy
• Kidney Diseases

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Lenox Hill Hospital	GE Healthcare

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of contrast induced nephropathy		48-72 hours	Yes