Brar Somjot S, Shen Albert Yuh-Jer, Jorgensen Michael B, Kotlewski Adam, Aharonian Vicken J, Desai Natasha, Ree Michael, Shah Ahmed Ijaz, Burchette Raoul J
Center for Interventional Vascular Therapy, Columbia University Medical Center, 161 Fort Washington Ave, Fifth Floor, New York, NY 10032, USA.
JAMA. 2008 Sep 3;300(9):1038-46. doi: 10.1001/jama.300.9.1038.
Sodium bicarbonate has been suggested as a possible strategy for prevention of contrast medium-induced nephropathy, a common cause of renal failure associated with prolonged hospitalization, increased health care costs, and substantial morbidity and mortality.
To determine if sodium bicarbonate is superior to sodium chloride for preventing contrast medium-induced nephropathy in patients with moderate to severe chronic kidney dysfunction who are undergoing coronary angiography.
DESIGN, SETTING, AND PATIENTS: Randomized, controlled, single-blind study conducted between January 2, 2006, and January 31, 2007, and enrolling 353 patients with stable renal disease who were undergoing coronary angiography at a single US center. Included patients were 18 years or older and had an estimated glomerular filtration rate of 60 mL/min per 1.73 m(2) or less and 1 or more of diabetes mellitus, history of congestive heart failure, hypertension, or age older than 75 years.
Patients were randomized to receive either sodium chloride (n = 178) or sodium bicarbonate (n = 175) administered at the same rate (3 mL/kg for 1 hour before coronary angiography, decreased to 1.5 mL/kg per hour during the procedure and for 4 hours after the completion of the procedure).
The primary end point was a 25% or greater decrease in the estimated glomerular filtration rate on days 1 through 4 after contrast exposure.
Median patient age was 71 (interquartile range, 65-76) years, and 45% had diabetes mellitus. The groups were well matched for baseline characteristics. The primary end point was met in 13.3% of the sodium bicarbonate group and 14.6% of the sodium chloride group (relative risk, 0.94; 95% confidence interval, 0.55-1.60; P = .82). In patients randomized to receive sodium bicarbonate vs sodium chloride, the rates of death, dialysis, myocardial infarction, and cerebrovascular events did not differ significantly at 30 days (1.7% vs 1.7%, 0.6% vs 1.1%, 0.6% vs 0%, and 0% vs 2.2%, respectively) or at 30 days to 6 months (0.6% vs 2.3%, 0.6% vs 1.1%, 0.6% vs 2.3%, and 0.6% vs 1.7%, respectively) (P > .10 for all).
The results of this study do not suggest that hydration with sodium bicarbonate is superior to hydration with sodium chloride for the prevention of contrast medium-induced nephropathy in patients with moderate to severe chronic kidney disease who are undergoing coronary angiography.
clinicaltrials.gov Identifier: NCT00312117.
碳酸氢钠已被提议作为预防造影剂肾病的一种可能策略，造影剂肾病是肾衰竭的常见病因，与住院时间延长、医疗费用增加以及高发病率和死亡率相关。
确定在接受冠状动脉造影的中重度慢性肾功能不全患者中，碳酸氢钠预防造影剂肾病是否优于氯化钠。
设计、地点和患者：2006年1月2日至2007年1月31日进行的随机、对照、单盲研究，纳入了美国一家中心353例接受冠状动脉造影的稳定肾病患者。纳入患者年龄在18岁及以上，估计肾小球滤过率为每分钟60毫升/1.73平方米或更低，且患有糖尿病、充血性心力衰竭病史、高血压或年龄超过75岁中的一种或多种。
患者被随机分为接受氯化钠（n = 178）或碳酸氢钠（n = 175），给药速率相同（冠状动脉造影前1小时3毫升/千克，术中及术后4小时减至1.5毫升/千克/小时）。
主要终点是造影剂暴露后第1至4天估计肾小球滤过率下降25%或更多。
患者中位年龄为71岁（四分位间距，65 - 76岁），45%患有糖尿病。两组基线特征匹配良好。碳酸氢钠组13.3%达到主要终点，氯化钠组为14.6%（相对危险度，0.94；95%置信区间，0.55 - 1.60；P = 0.82）。随机接受碳酸氢钠与氯化钠治疗的患者，30天时死亡、透析、心肌梗死和脑血管事件发生率无显著差异（分别为1.7%对1.7%，0.6%对1.1%，0.6%对零，零对2.2%），30天至6个月时也无显著差异（分别为0.6%对2.3%，0.6%对1.1%，0.6%对2.3%，0.6%对1.7%）（所有P均＞0.10）。
本研究结果并不表明，对于接受冠状动脉造影的中重度慢性肾病患者，用碳酸氢钠水化预防造影剂肾病优于用氯化钠水化。
clinicaltrials.gov标识符：NCT00312117。
