Schnuelle Peter, Gottmann Uwe, Hoeger Simone, Boesebeck Detlef, Lauchart Werner, Weiss Christel, Fischereder Michael, Jauch Karl-Walter, Heemann Uwe, Zeier Martin, Hugo Christian, Pisarski Przemyslaw, Krämer Bernhard K, Lopau Kai, Rahmel Axel, Benck Urs, Birck Rainer, Yard Benito Antonio
University Medical Centre Mannheim, 5th Department of Medicine, Theodor Kutzer Ufer 1-3, 68167 Mannheim, Germany.
JAMA. 2009 Sep 9;302(10):1067-75. doi: 10.1001/jama.2009.1310.
Kidney graft function after transplantation can be improved through pharmacological donor pretreatment to limit organ injury from cold preservation.
To determine whether pretreatment of brain-dead donors with low-dose dopamine improves early graft function in human renal transplant recipients.
DESIGN, SETTING, AND PATIENTS: Randomized, open-label, multicenter, parallel-group trial of 264 deceased heart-beating donors and 487 subsequent renal transplants performed at 60 European centers between March 2004 and August 2007 (final follow-up, December 31, 2008). Eligible donors were stable under low-dose norepinephrine with a normal serum creatinine concentration on admission.
Donors were randomized to receive low-dose dopamine (4 mug/kg/min).
Dialysis requirement during first week after transplantation.
Dopamine was infused for a median of 344 minutes (IQR, 215 minutes). Dialysis was significantly reduced in recipients of a dopamine-treated graft. Fewer recipients in the treatment group needed multiple dialyses (56/227; 24.7%; 95% CI, 19.0%-30.3%; vs 92/260; 35.4%; 95% CI, 29.5%-41.2%; P = .01). The need for multiple dialyses posttransplant was associated with allograft failure after 3 years (HR, 3.61; 95% CI, 2.39-5.45; P < .001), whereas a single dialysis was not (HR, 0.67; 95% CI, 0.21-2.18; P = .51). Besides donor dopamine (OR, 0.54; 95% CI, 0.35-0.83; P = .005), cold ischemic time (OR, 1.07; 95% CI, 1.02-1.11 per hour; P = .001), donor age (OR, 1.03; 95% CI, 1.01-1.05 per year; P < .001), and recipient body weight (OR, 1.02; 95% CI, 1.01-1.04 per kg; P = .009) were independent explanatory variables in a multiple logistic regression model. Dopamine resulted in significant but clinically meaningless increases in the donor's systolic blood pressure (3.8 mm Hg; 95% CI, 0.7-6.9 mm Hg; P = .02) and urine production before surgical recovery of the kidneys (29 mL; 95% CI, 7-51 mL; P = .009) but had no influence on outcome.
Donor pretreatment with low-dose dopamine reduces the need for dialysis after kidney transplantation.
clinicaltrials.gov Identifier: NCT00115115.
通过对供体进行药物预处理以限制冷保存对器官的损伤,可改善移植后肾移植的功能。
确定用小剂量多巴胺预处理脑死亡供体是否能改善人类肾移植受者的早期移植肾功能。
设计、地点和患者:2004年3月至2007年8月在60个欧洲中心进行的一项随机、开放标签、多中心、平行组试验,纳入264例心脏仍在跳动的已故供体及随后进行的487例肾移植(最终随访时间为2008年12月31日)。符合条件的供体在入院时使用小剂量去甲肾上腺素且血清肌酐浓度正常的情况下病情稳定。
将供体随机分组,接受小剂量多巴胺(4微克/千克/分钟)治疗。
移植后第一周的透析需求。
多巴胺输注的中位时间为344分钟(四分位间距,215分钟)。接受多巴胺处理过的移植物的受者透析需求显著减少。治疗组中需要多次透析的受者较少(56/227;24.7%;95%置信区间,19.0%-30.3%;与之相比,92/260;35.4%;95%置信区间,29.5%-41.2%;P = 0.01)。移植后需要多次透析与3年后移植肾失功相关(风险比,3.61;95%置信区间,2.39-5.45;P < 0.001),而单次透析则不然(风险比,0.67;95%置信区间,0.21-2.18;P = 0.51)。在多因素logistic回归模型中,除了供体多巴胺(比值比,0.54;95%置信区间,0.35-0.83;P = 0.005)外,冷缺血时间(比值比,1.07;95%置信区间,每小时1.02-1.11;P = 0.001)、供体年龄(比值比,1.03;95%置信区间,每年1.01-1.05;P < 0.001)和受者体重(比值比,1.02;95%置信区间,每千克1.01-1.04;P = 0.009)均为独立的解释变量。多巴胺使供体收缩压显著升高但临床意义不大(3.8毫米汞柱;95%置信区间,0.7-6.9毫米汞柱;P = 0.02),并使肾脏手术恢复前尿量增加(29毫升;95%置信区间,7-51毫升;P = 0.009),但对结局无影响。
用小剂量多巴胺预处理供体可减少肾移植后透析需求。
clinicaltrials.gov标识符:NCT00115115