Prevention of Contrast-Induced Nephropathy in Diabetic Patients With Undergoing Coronary Angiography

Study Overview
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Brief Summary
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The aim of this study is to determine whether sodium bicarbonate is superior to sodium chloride in preventing contrast induced nephropathy in diabetic patients undergoing coronary angiography or intervention.

Detailed Description
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Contrast induced nephropathy (CIN) is a common cause of renal failure associated with prolonged hospitalization, significant morbidity or mortality, and cost. CIN has been reported to account for 10% of hospital acquired renal failure. Several strategies or medications were tried to prevent CIN. Of these, mucomyst and normal saline infusion are effective to prevent CIN. Sodium bicarbonate has shown mixed results from recent randomized trials. Moreover,limited data have been available for preventing CIN in diabetic renal dysfunction undergoing coronary angiography or intervention. Our hypothesis is that addition of sodium bicarbonate will be more efficacious than normal saline in preventing CIN at above situation.

Official Title
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Preventive Strategies of REnal Insufficiency in Patients With Diabetes Undergoing InterVENTion or Arteriography(PREVENT Trial)

Conditions
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Contrast Induced Nephropathy

Intervention / Treatment
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* Drug: Sodium bicarbonate
* Drug: saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age>18 years, no upper limits diabetes treated with insulin or oral hypoglycemic agents serum creatinine >=1.1 and resting estimated glomerular filtration rate <60ml/min/1.73 square meter Exclusion Criteria: serum creatinine >=8mg/dL resting estimated GFR <15ml/min/1.73 square meter end stage renal disease on hemodialysis multiple myeloma uncontrolled hypertension (systolic BP >160mmHg or diastolic BP>100mmHg) acute myocardial infarction emergent coronary angioplasty or angiography recent use of contrast within 2 days allergic reaction to contrast pregnancy allergic to following medication : theophylline, dopamine, mannitol, fenoldopam, N-acetylcysteine

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sodium bicarbonate<br>sodium bicarbonate | Drug: Sodium bicarbonate<br>* 3 mL/kg for 1 hour immediately before contrast injection , 1mg/kg/hr during procedure and 6 hours after procedure<br>|
| Active Comparator: Saline<br>saline infusion | Drug: saline<br>* 0.9% normal saline with 1 mL/kg/hr infusion 12 hours before procedure and 12 hours after procedure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of contrast-induced nephropathy |  | 24 and 48 hours after angiography or intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all-cause mortality |  | 30 days after index angiography | 
| stroke |  | 30 days after index angiography | 
| Dialysis |  | 30 days after index angiography | 
| Myocardial infarction |  | 30 days after index angiography | 
| all-cause mortality |  | 30 days to 6 months after index angiography | 
| stroke |  | 30 days to 6 months after index angiography | 
| dialysis |  | 30 days to 6 months after index angiography | 
| myocardial infarction |  | 30 days to 6 months after index angiography | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sodium bicarbonate, diabetes mellitus, coronary angiography or intervention