HYDRATE: Oral Versus Intravenous Hydration to Prevent Contrast Induced Nephropathy

Sponsor

The Western Pennsylvania Hospital (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01093131

Collaborator

West Penn Allegheny Health System (Other)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Contrast Induced Nephropathy	Other: Oral hydration Drug: Oral sodium bicarbonate Other: Intravenous Hydration Drug: Intravenous sodium bicarbonate	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Feb 1, 2005

Actual Primary Completion Date :

Sep 1, 2009

Actual Study Completion Date :

Feb 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	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.
Active Comparator: 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.	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.
Active Comparator: 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	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
Active Comparator: 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	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

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Stable serum creatinine levels of at least 1.1 mg/dL or estimated creatinine clearance less than 60 mL/min
Scheduled for diagnostic, elective cardiac angiography

Exclusion Criteria:

Serum creatinine levels >8.0 mg/dL
Change in serum creatinine levels of at least 0.5 mg/dL during the previous 24 hours
Preexisting dialysis
Multiple myeloma or other myeloproliferative disease
Current CHF or recent history of flash pulmonary edema
Current myocardial infarction
Symptomatic hypokalemia
Uncontrolled hypertension (treated systolic blood pressure >200 mmHg or diastolic blood pressure >100mmHg)
Exposure to radiocontrast within 7 days the study
Emergency Catheterization
Allergy to radiographic contrast
Pregnancy
Administration of dopamine, mannitol, fenoldapam, or N-acetylcysteine during the time of the study
Severe COPD
Serum Bicarb > 28
Sodium <133