Bicarbonate v Saline to Prevent Contrast Nephropathy

Study Overview
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Brief Summary
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Slowing of kidney function occurs in a minority of people given dye during angiography. The purpose of this study is to compare two different types of fluid given into a vein to reduce the risk of kidney injury: salt in water or baking soda in water.

Detailed Description
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A decline in kidney function after contrast is associated with prolonged hospital stay, adverse cardiac events, and higher mortality both in hospital and in the long term. Deliberate administration of fluids is recommended to reduce the risk of contrast nephropathy. However, data to support specific recommendations are lacking and the optimal fluid regimen remains unclear. It has been hypothesized that alkalinization of tubular fluid might be beneficial by reducing pH dependent free radical levels. A recent trial found a lower frequency of creatinine rise > 25% within two days of contrast with a 7 hour infusion of isotonic sodium bicarbonate than with saline infusion (Merten GJ, JAMA 2004). However, it remains to be proven that bicarbonate is superior as this trial has a number of methodological flaws. Comparison: IV 1/6 M sodium bicarbonate OR IV 0.9% saline, each isotonic fluid given at the same rate of sodium administration (3.25 ml/Kg over 1 hour pre-contrast, followed by 1.1 ml/Kg/hr for 6 hours for bicarbonate; 3.5 ml/Kg over 1 hour pre-contrast, followed by 1.2 ml/Kg/hr for 6 hours for saline). Total infusion time 7 hours (for both). Maximum rate of fluid permitted is that for a body weight of 110 Kg. Intra-vascular iso- or low-osmolality contrast in the minimal dose needed to complete the required imaging.

Official Title
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Phase 4 Study of Bicarbonate Versus Saline Infusion Therapy to Prevent Contrast Induced Nephropathy (CAN-IT PREVENT Protocol)

Conditions
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Kidney Failure, Acute, Contrast Media

Intervention / Treatment
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* Drug: 0.9% (154 mEq/L) IV Sodium Chloride
* Drug: 1/6 M (166 mEq/L) IV Sodium Bicarbonate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Booked for cardiac or other non-renal arteriography Pre-existing reduced kidney function: Serum Creatinine >= 1.3 & <= 4 mg/dl (female gender) or >= 1.5 & <= 5 mg/dl (male gender) Age > 18 years Exclusion Criteria: GFR MDRD estimate < 15 ml/min/m2 End-stage renal disease already on dialysis Known current Acute Kidney Failure with serum creatinine rise of > 0.5 mg/dl within 24 hours Pulmonary edema - current or within 48 hours Clinically relevant ascites, edema or other fluid overload Uncontrolled hypertension (> 165 mmHg systolic, or > 105 mmHg diastolic) Hemodynamically unstable patient requiring IV nitroglycerine, or IV fluid or inotropes for blood pressure support Emergency (unplanned) angiography IV contrast procedure Exposure to iodinated radiocontrast within 3 days prior to study Prior anaphylactoid reaction to contrast Planned administration of N-acetylcysteine Planned administration of dopamine, fenoldopam or mannitol Current pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bicarbonate<br>Bicarbonate solution infusion | Drug: 1/6 M (166 mEq/L) IV Sodium Bicarbonate<br>* Bicarbonate solution<br>* Other names: Sodium Bicarbonate;|
| Active Comparator: Saline<br>Standard volume expansion | Drug: 0.9% (154 mEq/L) IV Sodium Chloride<br>* Saline solution<br>* Other names: Sodium Chloride;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of contrast-induced nephropathy, CIN, defined as an increase in serum creatinine of 25% or more from pre-intervention baseline to within 48-72 hours after administration of the radiographic contrast. |  | 48-72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Group mean change in serum creatinine |  | 48-72 hours | 
| Days in hospital within the week post contrast |  | One week | 
| Requirement for dialysis |  | Two months | 
| Atheroembolic events |  | Two months | 
| Major adverse cardiovascular events |  | Two months | 
| Death |  | Two months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contrast Induced Nephropathy, Chronic Kidney Disease, Acute Renal Failure, End-stage Renal Disease, Cardiovascular diseases, Coronary catheterization, Percutaneous coronary intervention, Intra-arterial angiography, Bicarbonate, Saline