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Randomized Controlled Trial
Sodium bicarbonate plus isotonic saline versus saline for prevention of contrast-induced nephropathy in patients undergoing coronary angiography: a randomized controlled trial.
- Ali Vasheghani-Farahani, Gelareh Sadigh, Seyed Ebrahim Kassaian, Seyed Mohammad Reza Khatami, Akbar Fotouhi, Seyed Amir Hossein Razavi, Mohammad Ali Mansournia, Ahmad Yamini-Sharif, Alireza Amirzadegan, Mojtaba Salarifar, Saeed Sadeghian, Gholamreza Davoodi, Mohammad Ali Borumand, Farah Aiatollahzade Esfehani, and Sirous Darabian.
- Department of Cardiology, Tehran Heart Center, Tehran University of Medical Sciences, Tehran, Iran.
- Am. J. Kidney Dis. 2009 Oct 1;54(4):610-8.
BackgroundThere is controversy about the prophylactic measures proposed for the prevention of contrast-induced nephropathy (CIN). We aim to compare the efficacy of the combination of sodium bicarbonate and isotonic saline and that of isotonic saline alone in preventing CIN.Study DesignRandomized double-blind controlled trial.Setting & Participants265 consecutive patients 18 years or older with a serum creatinine level of 1.5 mg/dL or greater undergoing elective coronary angiography from August 2007 to June 2008 in Tehran Heart Center, Tehran, Iran.InterventionStudy participants were randomly assigned to receive either 75 mL of 8.4% sodium bicarbonate added to 1 L of isotonic saline (n = 135) or isotonic saline alone (n = 130) as a bolus of 3 mL/kg for 1 hour before contrast injection, followed by an infusion of 1 mL/kg/h for 6 hours after the procedure.Outcomes & MeasurementsThe primary end point was an absolute (>or=0.5 mg/dL) or relative (>or=25%) increase in serum creatinine level 48 hours after the procedure (CIN).ResultsThere were no significant differences between the bicarbonate and saline groups regarding baseline demographic and biochemical characteristics, including baseline serum creatinine level (1.63 +/- 0.32 [SD] versus 1.66 +/- 0.50 mg/dL), baseline glomerular filtration rate (46.4 +/- 12 versus 45.4 +/- 12 mL/min/1.73 m(2)), and baseline urine pH (5.42 +/- 0.6 versus 5.46 +/- 0.8). Nine patients (7.4%) receiving sodium bicarbonate developed CIN as opposed to 7 patients (5.9%) in the saline group, which was not statistically different (odds ratio, 1.26; 95% confidence interval, 0.45 to 3.50; P = 0.6).LimitationsThe trial did not follow up participants to assess need for dialysis and mortality rate.ConclusionThe combination therapy of sodium bicarbonate plus saline does not offer additional benefits over hydration with saline alone in the prevention of CIN.
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