Hydration and Contrast-Induced Nephropathy in Primary Angioplasty
Phase 4
Completed
- Conditions
- Contrast Induced Nephropathy
- Interventions
- Drug: sodium bicarbonate solutionDrug: Isotonic salineDrug: Placebo
- Registration Number
- NCT00770614
- Lead Sponsor
- Ospedale Misericordia e Dolce
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 450
Inclusion Criteria
- patients with Acute ST Elevation Myocardial Infarction submitted to Primary Intervention
Exclusion Criteria
- refusal to consent
- previous contrast exposure within 72 hours
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 sodium bicarbonate solution 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 2 Isotonic saline Isotonic Saline (0.9% sodium chloride) 1 mL/kg/h for 12 hours after the procedure 3 Placebo Placebo
- Primary Outcome Measures
Name Time Method 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 within 5 days after contrast exposure
- Secondary Outcome Measures
Name Time Method Adverse clinical events within 1 month, including in-hospital death and need for dialysis or hemofiltration 1 month
Trial Locations
- Locations (1)
Ospedale Misericordia e Dolce
🇮🇹Prato, Italy