Early Hydration in Acute Myocardial Infarction: Sodium Bicarbonate Versus Saline for the Prevention on Contrast-induced Acute Kidney Injury
Overview
- Phase
- Phase 4
- Intervention
- sodium bicarbonate solution
- Conditions
- Contrast Induced Acute Kidney Injury
- Sponsor
- Ospedale Misericordia e Dolce
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Incidence of contrast-induced acute kidney injury
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
The purpose of this study is to determine whether hydration with sodium bicarbonate is more effective than hydration with sodium chloride to prevent contrast nephropathy in patients undergoing primary coronary intervention for acute ST elevation myocardial infarction.
Investigators
Mauro Maioli
Medical Doctor
Ospedale Misericordia e Dolce
Eligibility Criteria
Inclusion Criteria
- •Consecutive patients with AMI candidates for primary PCI presenting within 12 h of symptom onset with ST-segment elevation of more 1 mm in at least two contiguous leads of electrocardiogram.
Exclusion Criteria
- •contrast medium administration within the 10 days
- •end-stage renal failure requiring dialysis
- •refusal to give informed consent
Arms & Interventions
Sodium bicarbonate
Sodium Bicarbonate (154 mEq/L in dextrose and H2O) 3 mL/kg for 1 hour before contrast medium, followed by an infusion of 1 mL/kg/h for 12 hours after the procedure
Intervention: sodium bicarbonate solution
Saline
Sodium Saline 3 mL/kg for 1 hour before contrast medium, followed by an infusion of 1 mL/kg/h for 12 hours after the procedure
Intervention: Isotonic saline
Outcomes
Primary Outcomes
Incidence of contrast-induced acute kidney injury
Time Frame: 2 days
contrast-induced acute kidney injury is defined as an increase in serum creatinine \>= 0.3 mg/dL over the baseline value within 2 days after the administration of the contrast medium
Secondary Outcomes
- adverse clinical events(1 month)