Contrast Induced Nephropathy Clinical Trial
Official title:
Randomized Trial on the Effects of Hydration With Sodium Chloride Versus Sodium Bicarbonate to Prevent Contrast Induced Nephropathy, in Patients Undergoing Primary Coronary Interventions for Acute ST Elevation Myocardial Infarction.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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