Hydration and Contrast-Induced Nephropathy in Primary Angioplasty. A Randomized, Placebo Controlled, Trial.
Overview
- Phase
- Phase 4
- Intervention
- sodium bicarbonate solution
- Conditions
- Contrast Induced Nephropathy
- Sponsor
- Ospedale Misericordia e Dolce
- Enrollment
- 450
- Locations
- 1
- Primary Endpoint
- Absolute increase of at least 0.5 mg/dl from the baseline value in serum creatinine concentration or a relative increase ≥ 25% over baseline serum creatinine within 5 days after contrast agent administration
- Status
- Completed
- Last Updated
- 13 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 induced nephropathy in patients undergoing Primary Coronary Intervention for Acute ST Elevation Myocardial Infarction.
Investigators
Mauro Maioli
MD
Ospedale Misericordia e Dolce
Eligibility Criteria
Inclusion Criteria
- •patients with Acute ST Elevation Myocardial Infarction submitted to Primary Intervention
Exclusion Criteria
- •refusal to consent
- •previous contrast exposure within 72 hours
Arms & Interventions
1
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
2
Isotonic Saline (0.9% sodium chloride) 1 mL/kg/h for 12 hours after the procedure
Intervention: Isotonic saline
3
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Absolute increase of at least 0.5 mg/dl from the baseline value in serum creatinine concentration or a relative increase ≥ 25% over baseline serum creatinine within 5 days after contrast agent administration
Time Frame: within 5 days after contrast exposure
Secondary Outcomes
- Adverse clinical events within 1 month, including in-hospital death and need for dialysis or hemofiltration(1 month)