Oral Versus Intravenous Hydration to Prevent Contrast Induced Nephropathy (HYDRATE)

The Western Pennsylvania Hospital

Status and phase: Withdrawn; Phase 4

Conditions: Contrast Induced Nephropathy

Treatments: Drug: Oral sodium bicarbonate; Drug: Intravenous sodium bicarbonate; Other: Oral hydration; Other: Intravenous Hydration

Study type: Interventional

Funder types: Other

Identifiers

NCT01093131

04-11-097-DT / WPCI 2009-28

Details and patient eligibility

About

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.

Full description

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.

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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0 participants in 4 patient groups

Intravenous Hydration

Active Comparator group

Description:

Pretreatment with a 3 mL/kg bolus of intravenous normal saline solution (154 mEq/L) over 1 hour, immediately prior to contrast exposure followed by intravenous infusion of 1ml/kg per for 6 hours after the procedure.

Treatment:

Other: Intravenous Hydration

Intravenous hydration and sodium bicarbonate

Active Comparator group

Description:

Pretreatment with a 3 mL/kg bolus of intravenous sodium bicarbonate solution (154 mEq/L) over 1 hour, immediately prior to contrast exposure followed by intravenous infusion of 1 mL/kg for 6 hours after the procedure.

Treatment:

Other: Intravenous Hydration

Drug: Intravenous sodium bicarbonate

Oral hydration

Active Comparator group

Description:

Oral hydration with 500 mL of water to be started 4 hours prior to contrast exposure and stopped 2 hours prior to procedure followed by oral hydration with 600 mL of water post procedure

Treatment:

Other: Oral hydration

Oral hydration and oral sodium bicarbonate

Active Comparator group

Description:

Oral hydration with 500 mL of water to be started 4 hours prior to procedure and stopped 2 hours prior to contrast exposure, with the addition of 3.9 grams (46.4 mEq) of oral sodium bicarbonate to be given 20 minutes prior to contrast exposure followed by 1.95 grams (30.4 mEq) of oral sodium bicarbonate 2 hours and 4 hours after the initial dose

Treatment:

Drug: Oral sodium bicarbonate

Other: Oral hydration