Trials / Terminated
TerminatedNCT00494637
The Use of Sodium Bicarbonate in the Prevention of Contrast Induced Nephropathy
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 468 (estimated)
- Sponsor
- Lenox Hill Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | sodium bicarbonate | isotonic sodium bicarbonate at 3 cc/kg for one hour followed by 2 cc kg/hr for 4 hours |
Timeline
- Start date
- 2007-07-01
- Primary completion
- 2008-12-01
- Completion
- 2009-01-01
- First posted
- 2007-07-02
- Last updated
- 2009-01-28
Source: ClinicalTrials.gov record NCT00494637. Inclusion in this directory is not an endorsement.