Preventive Strategies of REnal Insufficiency in Patients With Diabetes Undergoing InterVENTion or Arteriography(PREVENT Trial)
Overview
- Phase
- Phase 4
- Intervention
- Sodium bicarbonate
- Conditions
- Contrast Induced Nephropathy
- Sponsor
- CardioVascular Research Foundation, Korea
- Enrollment
- 368
- Locations
- 9
- Primary Endpoint
- Incidence of contrast-induced nephropathy
- Last Updated
- 16 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Sodium bicarbonate
sodium bicarbonate
Intervention: Sodium bicarbonate
Saline
saline infusion
Intervention: saline
Outcomes
Primary Outcomes
Incidence of contrast-induced nephropathy
Time Frame: 24 and 48 hours after angiography or intervention
Secondary Outcomes
- all-cause mortality(30 days to 6 months after index angiography)
- stroke(30 days to 6 months after index angiography)
- Dialysis(30 days after index angiography)
- Myocardial infarction(30 days after index angiography)
- dialysis(30 days to 6 months after index angiography)
- myocardial infarction(30 days to 6 months after index angiography)