Oral Versus Intravenous Hydration to Prevent Contrast Induced Nephropathy

• Status: Withdrawn
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The increased risk for contrast-induced nephropathy (CIN) in patients with chronic kidney disease (CKD) undergoing coronary angiography (CAG) has been established. Current and historical data on CIN prevention strategies have shown wide variation with respect to the optimal type, route and timing of these therapies. We investigate the role for oral hydration and/or oral sodium bicarbonate administration compared to intravenous hydration and/or sodium bicarbonate in patients with CKD undergoing CAG.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: The Western Pennsylvania Hospital
• Collaborator: West Penn Allegheny Health System
• Treatments: Pharmaceutical Solutions

Criteria

Inclusion Criteria:

1. Stable serum creatinine levels of at least 1.1 mg/dL or estimated creatinine clearance less than 60 mL/min

2. Scheduled for diagnostic, elective cardiac angiography

Exclusion Criteria:

1. Serum creatinine levels >8.0 mg/dL

2. Change in serum creatinine levels of at least 0.5 mg/dL during the previous 24 hours

3. Preexisting dialysis

4. Multiple myeloma or other myeloproliferative disease

5. Current CHF or recent history of flash pulmonary edema

6. Current myocardial infarction

7. Symptomatic hypokalemia

8. Uncontrolled hypertension (treated systolic blood pressure >200 mmHg or diastolic blood pressure >100mmHg)

9. Exposure to radiocontrast within 7 days the study

10. Emergency Catheterization

11. Allergy to radiographic contrast

12. Pregnancy

13. Administration of dopamine, mannitol, fenoldapam, or N-acetylcysteine during the time of the study

14. Severe COPD

15. Serum Bicarb > 28

16. Sodium <133