Oral Versus Intravenous Hydration to Prevent Contrast Induced Nephropathy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Contrast Induced Nephropathy

Intervention / Treatment
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* Other: Oral hydration
* Drug: Oral sodium bicarbonate
* Other: Intravenous Hydration
* Drug: Intravenous sodium bicarbonate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intravenous Hydration<br>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<br>* 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.<br>|
| Active Comparator: Intravenous hydration and sodium bicarbonate<br>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<br>* 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.<br>Drug: Intravenous sodium bicarbonate<br>* 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.<br>|
| Active Comparator: Oral hydration<br>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<br>* 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<br>|
| Active Comparator: Oral hydration and oral sodium bicarbonate<br>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<br>* 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<br>Drug: Oral sodium bicarbonate<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contrast induced nephropathy, Percutaneous transluminal coronary angioplasty, chronic kidney disease, Prevention, Equivalence