Oral Versus Intravenous Hydration to Prevent Contrast Induced Nephropathy

Contrast Induced Nephropathy Clinical Trial

— HYDRATE  

Official title:

Oral Hydration and Alkalinization is Non-Inferior to Intravenous Therapy for Prevention of Contrast Induced Nephropathy in Patients With Chronic Kidney Disease.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01093131
• Other study ID #: 04-11-097-DT / WPCI 2009-28
• Status: Withdrawn
• Phase: Phase 4
• Start date: February 2005
• Est. completion date: February 2010

Study information

• Verified date: November 2016
• Source: The Western Pennsylvania Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2010
• Est. primary completion date: September 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Contrast Induced Nephropathy
• Kidney Diseases

Intervention

Other:
• 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

Drug:
• 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

Other:
• 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.

Drug:
• 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.

Locations

Country	Name	City	State
United States	The Western Pennsylvania Hospital	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
The Western Pennsylvania Hospital	West Penn Allegheny Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Contrast 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.	72 hours
Secondary	Length of Hospital Stay	Defined as number of days in the hospital.	72 hours
Secondary	In-Hospital Mortality	Any cause of mortality	72 hours
Secondary	Aspiration	Defined as oxygen saturation less than 92% by pulse oximetry.	72 hours
Secondary	Hypotension	Defined as a systolic blood pressure less than 100 mmHg by conventional measuring methods.	72 hours

External Links

•   Western Pennsylvania Allegheny Health System