Prevention of contrast-induced nephropathy with sodium bicarbonate - A randomized controlled trial

Prevention of contrast-induced nephropathy with sodium bicarbonate - A randomized controlled trial
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DOI:
10.1001/jama.291.19.2328
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发表时间:
2004-05-19
影响因子:
120.7
通讯作者:
Kennedy, TP
Kennedy, TP
中科院分区:
医学1区
文献类型:
--
作者:
Merten, GJ;Burgess, WP;Kennedy, TP

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造影剂肾病仍然是影像学检查的常见并发症。在急性缺血性肾衰竭动物模型中,碳酸氢钠预处理比氯化钠更有保护作用。缺血和造影剂引起的急性肾功能衰竭被认为是自由基损伤引起的。然而,没有人类或动物研究评估碳酸氢钠预防造影剂肾病的功效。目的比较碳酸氢钠与氯化钠在造影前后预防水化的效果。设计、环境和患者:一项前瞻性、单中心、随机试验,于2002年9月16日至2003年6月17日进行,纳入119例血清肌酐水平稳定在1.1 mg/dL(大于或等于97.2 mumol/L)以上的患者,随机分组,在给予iopamidol (370 mg碘/mL)前后分别接受154 meq /L的氯化钠(n = 59)或碳酸氢钠(n = 60)输注。在基线和对比后1、2天测定血清肌酐水平。干预措施:患者在iopamidol造影剂前1小时接受154 mEq/L氯化钠或碳酸氢钠,剂量为3ml /kg /小时,术后6小时输注1ml /kg /小时。对比剂肾病,定义为对比剂2天内血清肌酐升高25%或以上。结果两组患者在年龄、性别、糖尿病发病率、种族、造影剂体积等方面无显著差异。接受碳酸氢钠治疗的患者基线血清肌酐略高,但无统计学差异(氯化钠组平均[SD]为1.71 [0.42]mg/dL [151.2 {37.1} mumol/L],碳酸氢钠组平均[SD]为1.89 [0.69]mg/dL [167.1 {61.0} mumol/L], P = 0.09)。造影剂肾病的主要终点发生在输注氯化钠的8例(13.6%)患者中,而输注碳酸氢钠的患者中只有1例(1.7%)出现造影剂肾病(平均差为11.9%;95%可信区间[Cl], 2.6%-21.2%; P = 0.02)。191例患者连续接受预防性碳酸氢钠治疗,符合与研究相同的纳入标准,随访登记结果为3例造影剂肾病(1.6%;95% Cl, 0%-3.4%)。结论造影剂暴露前碳酸氢钠水化比氯化钠水化对预防造影剂引起的肾功能衰竭更有效。
Context Contrast-induced nephropathy remains a common complication of radiographic procedures. Pretreatment with sodium bicarbonate is more protective than sodium chloride in animal models of acute ischemic renal failure. Acute renal failure from both ischemia and contrast are postulated to occur from free-radical injury. However, no studies in humans or animals have evaluated the efficacy of sodium bicarbonate for prophylaxis against contrast-induced nephropathy.Objective To examine the efficacy of sodium bicarbonate compared with sodium chloride for preventive hydration before and after radiographic contrast.Design, Setting, and Patients A prospective, single-center, randomized trial conducted from September 16, 2002, to June 17, 2003, of 119 patients with stable serum creatinine levels of at least 1.1 mg/dL (greater than or equal to97.2 mumol/L) who were randomized to receive a 154-mEq/L infusion of either sodium chloride (n = 59) or sodium bicarbonate (n = 60) before and after iopamidol administration (370 mg iodine/mL). Serum creatinine levels were measured at baseline and 1 and 2 days after contrast.Interventions Patients received 154 mEq/L of either sodium chloride or sodium bicarbonate, as a bolus of 3 mL/kg per hour for 1 hour before iopamidol contrast, followed by an infusion of 1 mL/kg per hour for 6 hours after the procedure.Main Outcome Measure Contrast-induced nephropathy, defined as an increase of 25% or more in serum creatinine within 2 days of contrast.Results There were no significant group differences in age, sex, incidence of diabetes mellitus, ethnicity, or contrast volume. Baseline serum creatinine was slightly higher but not statistically different in patients receiving sodium bicarbonate treatment (mean [SD], 1.71 [0.42] mg/dL [151.2 {37.1} mumol/L] for sodium chloride and 1.89 [0.69] mg/dL [167.1 {61.0} mumol/L] for sodium bicarbonate; P = .09). The primary end point of contrast-induced nephropathy occurred in 8 patients (13.6%) infused with sodium chloride but in only 1 (1.7%) of those receiving sodium bicarbonate (mean difference, 11.9%; 95% confidence interval [Cl], 2.6%-21.2%; P = .02). A follow-up registry of 191 consecutive patients receiving prophylactic sodium bicarbonate and meeting the same inclusion criteria as the study resulted in 3 cases of contrast-induced nephropathy (1.6%; 95% Cl, 0%-3.4%).Conclusion Hydration with sodium bicarbonate before contrast exposure is more effective than hydration with sodium chloride for prophylaxis of contrast-induced renal failure.