Oral Versus Intravenous Hydration to Prevent Contrast Induced Nephropathy
| Status: | Completed |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease, Nephrology |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - 100 |
| Updated: | 12/1/2016 |
| Start Date: | February 2005 |
| End Date: | February 2010 |
Oral Hydration and Alkalinization is Non-Inferior to Intravenous Therapy for Prevention of Contrast Induced Nephropathy in Patients With Chronic Kidney Disease.
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.
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.
This is a single center study randomizing patients with CKD undergoing CAG into 4 groups: 1)
Intravenous normal saline, 2) Intravenous normal saline and intravenous bicarbonate, 3) oral
hydration, and 4) oral hydration and oral bicarbonate. The primary endpoint was the
occurrence of contrast-medium-induced nephropathy defined as greater than 25% increase in
serum creatinine from baseline or an absolute increase of 0.5 mg/dL from baseline at 72
hours following exposure to radiocontrast. Secondary endpoints include the length of
hospitalization and in-house mortality.
Intravenous normal saline, 2) Intravenous normal saline and intravenous bicarbonate, 3) oral
hydration, and 4) oral hydration and oral bicarbonate. The primary endpoint was the
occurrence of contrast-medium-induced nephropathy defined as greater than 25% increase in
serum creatinine from baseline or an absolute increase of 0.5 mg/dL from baseline at 72
hours following exposure to radiocontrast. Secondary endpoints include the length of
hospitalization and in-house mortality.
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
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