Kidney Diseases Clinical Trial
Official title:
A Prospective Study on Incidence and Prevention of Contrast-induced Nephropathy in Croatia With the Use of Standard Laboratory Measures and Novel Biomarkers
The study is analysis of the incidence of contrast-induced nephropathy (CIN) in patients
with previously normal renal function undergoing angiography and comparison between the
three different treatment protocols on renal function.
Patients are randomly assigned to the three groups: 1) peroral hydration, 2) Na bicarbonate
(NaHCO3), and 3) NaHCO3 plus N-acetylcysteine (NAC) infusion.
Serum creatinine (SCr), blood urea nitrogen (BUN), and neutrophil gelatinase-associated
lipocalin (NGAL) are measured before and 48 hours after the angiography. CIN was defined as
an absolute increase of 0.5 mg/dL or a relative increase of >25% in creatinine levels 48-72
hours after the procedure
Patients are randomly assigned to the three groups: 1) peroral hydration, 2) Na bicarbonate
(NaHCO3), and 3) NaHCO3 plus N-acetylcysteine (NAC) infusion The first group of patients
receives standard peroral hydration of 1500 ml water on the day of the procedure.
The second group receives 3 mL/kg/hour of Na bicarbonate, an hour prior to angiography and 1
mL/kg/hour, within six hours after angiography.
The third group receives parenteral NAC (1200 mg twice a day) one day before angiography, on
the day of the angiography, and one day after the diagnostic procedure in addition to Na
bicarbonate solution on the day of the angiography.
The low-osmolar iodinated contrast agent was used.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention
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