Oral Versus Intravenous Hydration to Prevent Contrast Induced Nephropathy

NCT ID: NCT01093131

Last Updated: 2019-10-04

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-02-28
• Study Completion Date: 2010-02-28

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.

Conditions

Contrast Induced Nephropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Intravenous Hydration

Intervention Type: OTHER

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

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.

Group Type: ACTIVE_COMPARATOR

Intravenous Hydration

Intervention Type: OTHER

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 sodium bicarbonate

Intervention Type: DRUG

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 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

Group Type: ACTIVE_COMPARATOR

Oral hydration

Intervention Type: OTHER

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 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

Group Type: ACTIVE_COMPARATOR

Oral hydration

Intervention Type: OTHER

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 sodium bicarbonate

Intervention Type: DRUG

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

Interventions

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

Intervention Type: OTHER

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

Intervention Type: DRUG

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.

Intervention Type: OTHER

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.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

West Penn Allegheny Health System

OTHER

Sponsor Role: collaborator

The Western Pennsylvania Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roy Cho, MD MHSA

Role: STUDY_DIRECTOR

The Western Pennsylvania Hospital

Locations

The Western Pennsylvania Hospital

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

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

Identifier Type: -

Identifier Source: org_study_id