The aim of the study is to test the efficacy of low versus high volume hydration and two different solutions (sodium chloride versus sodium bicarbonate) in preventing contrast induced nephropathy (CIN) in ST elevation myocardial infarction (STEMI) patients undergoing primary PCI.
Contrast-induced nephropathy (CIN) is associated with increased morbidity and mortality after percutaneous coronary interventions (PCI). Patients with ST elevation myocardial infarction (STEMI) are at high risk for CIN because of hemodynamic instability of the patient, inability to prevent the phenomenon (hydration) and the possible exposure to high volume of contrast media. Recent reports have shown incidence of CIN up to 19% in this population and a related increase of in-hospital mortality. Merten e coll. (JAMA 2004) reported that sodium bicarbonate infusion before and after contrast exposure in patients with chronic renal failure and without myocardial infarction (AMI) is more effective than sodium chloride in preventing CIN. Up to date there is no evidence of any effective prophylactic measures in patients with STEMI undergoing primary PCI. The aim of the study is to test the efficacy of low versus high volume hydration and the efficacy of two different solutions (sodium chloride versus sodium bicarbonate) in preventing CIN in STEMI patients undergoing primary PCI. The infusion of the randomized solution will start just after randomization and after determination of baseline serum creatinine. Determination of serum creatinine will be repeated at 24, 48 and 72 hours after randomization. Creatinine clearance will be calculated with Cockroft-Gault formula and MDRD.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
599
Solution of 154 mEq/L of sodium chloride. Rate of infusion: 1 ml/Kg/hour for 12 hours.
Solution of 154 mEq/L of sodium chloride. Rate of infusion: 3 ml/Kg for 1 hour, followed by 1 ml/Kg/hour for 12 hours
154 mEq/L of sodium bicarbonate in dextrose solution. Rate of infusion: 1 ml/Kg/hour for 12 hours.
Azienda Ospedaliera Universitaria S. Anna
Ferrara, Emilia-Romagna, Italy
Nuovo Ospedale Civile di Baggiovara
Modena, Emilia-Romagna, Italy
Arcispedale S. Maria Nuova
Reggio Emilia, Emilia-Romagna, Italy
Dipartimento di Cardiologia, Ospedale di Lavagna
Lavagna, Genova, Italy
contrast induced nephropathy incidence
Time frame: 24, 48 and 72 hours
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154 mEq/L of sodium chloride in dextrose solution. Rate of infusion: 3 ml/Kg for 1 hour, followed by 1 ml/Kg/hour for 12 hours.
Dipartimento di Cardiologia, Ospedale Maggiore
Parma, Parma, Italy