Oral Versus Intravenous Hydration to Prevent Contrast Induced Nephropathy

Phase 4

Withdrawn

• Conditions: Contrast Induced Nephropathy
• Interventions: Other: Intravenous Hydration; Other: Oral hydration; Drug: Intravenous sodium bicarbonate; Drug: Oral sodium bicarbonate

• Registration Number: NCT01093131
• Lead Sponsor: The Western Pennsylvania Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2005-02
• Primary Completion: 2009-09
• Study Completion: 2010-02
• Study First Submitted: 2010-02-25
• Study First Submitted QC: 2010-03-23
• Study First Posted: 2010-03-25
• Status Verified: 2016-11
• Last Update Submitted: 2019-10-01
• Last Update Posted: 2019-10-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Intravenous Hydration	Intravenous Hydration	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.
Intravenous hydration and sodium bicarbonate	Intravenous Hydration	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.
Intravenous hydration and sodium bicarbonate	Intravenous sodium bicarbonate	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.
Oral hydration	Oral hydration	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
Oral hydration and oral sodium bicarbonate	Oral hydration	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
Oral hydration and oral sodium bicarbonate	Oral sodium bicarbonate	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

Primary Outcome Measures

Name	Time	Method
Contrast Induced Nephropathy	72 hours	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.

Secondary Outcome Measures

Name	Time	Method
Length of Hospital Stay	72 hours	Defined as number of days in the hospital.
In-Hospital Mortality	72 hours	Any cause of mortality
Aspiration	72 hours	Defined as oxygen saturation less than 92% by pulse oximetry.
Hypotension	72 hours	Defined as a systolic blood pressure less than 100 mmHg by conventional measuring methods.

Trial Locations

Locations (1)

The Western Pennsylvania Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States