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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00494637

Enrollment

468

Registered

2007-07-02

Start date

2007-07-31

Completion date

2009-01-31

Last updated

2009-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contrast Induced Nephropathy

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.

Interventions

DRUGsodium bicarbonate

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Incidence of contrast induced nephropathy	48-72 hours

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026