Costanzo Maria Rosa, Guglin Maya E, Saltzberg Mitchell T, Jessup Mariell L, Bart Bradley A, Teerlink John R, Jaski Brian E, Fang James C, Feller Erika D, Haas Garrie J, Anderson Allen S, Schollmeyer Michael P, Sobotka Paul A
Midwest Heart Foundation, Edward Heart Hospital, Lombard, Illinois 60566, USA.
J Am Coll Cardiol. 2007 Feb 13;49(6):675-83. doi: 10.1016/j.jacc.2006.07.073. Epub 2007 Jan 26.
This study was designed to compare the safety and efficacy of veno-venous ultrafiltration and standard intravenous diuretic therapy for hypervolemic heart failure (HF) patients.
Early ultrafiltration may be an alternative to intravenous diuretics in patients with decompensated HF and volume overload.
Patients hospitalized for HF with > or =2 signs of hypervolemia were randomized to ultrafiltration or intravenous diuretics. Primary end points were weight loss and dyspnea assessment at 48 h after randomization. Secondary end points included net fluid loss at 48 h, functional capacity, HF rehospitalizations, and unscheduled visits in 90 days. Safety end points included changes in renal function, electrolytes, and blood pressure.
Two hundred patients (63 +/- 15 years, 69% men, 71% ejection fraction < or =40%) were randomized to ultrafiltration or intravenous diuretics. At 48 h, weight (5.0 +/- 3.1 kg vs. 3.1 +/- 3.5 kg; p = 0.001) and net fluid loss (4.6 vs. 3.3 l; p = 0.001) were greater in the ultrafiltration group. Dyspnea scores were similar. At 90 days, the ultrafiltration group had fewer patients rehospitalized for HF (16 of 89 [18%] vs. 28 of 87 [32%]; p = 0.037), HF rehospitalizations (0.22 +/- 0.54 vs. 0.46 +/- 0.76; p = 0.022), rehospitalization days (1.4 +/- 4.2 vs. 3.8 +/- 8.5; p = 0.022) per patient, and unscheduled visits (14 of 65 [21%] vs. 29 of 66 [44%]; p = 0.009). No serum creatinine differences occurred between groups. Nine deaths occurred in the ultrafiltration group and 11 in the diuretics group.
In decompensated HF, ultrafiltration safely produces greater weight and fluid loss than intravenous diuretics, reduces 90-day resource utilization for HF, and is an effective alternative therapy. (The UNLOAD trial; http://clinicaltrials.gov/ct/show/NCT00124137?order=1; NCT00124137).
本研究旨在比较静脉-静脉超滤与标准静脉利尿剂治疗对高血容量性心力衰竭(HF)患者的安全性和有效性。
早期超滤可能是失代偿性HF和容量超负荷患者静脉利尿剂的替代治疗方法。
因HF住院且有≥2项高血容量体征的患者被随机分为超滤组或静脉利尿剂组。主要终点为随机分组后48小时的体重减轻和呼吸困难评估。次要终点包括48小时的净液体丢失、功能能力、HF再住院率以及90天内的非计划就诊。安全终点包括肾功能、电解质和血压的变化。
200例患者(63±15岁,69%为男性,71%射血分数≤40%)被随机分为超滤组或静脉利尿剂组。48小时时,超滤组的体重(5.0±3.1kg对3.1±3.5kg;p = 0.001)和净液体丢失(4.6对3.3L;p = 0.001)更多。呼吸困难评分相似。90天时,超滤组因HF再住院的患者更少(89例中的16例[18%]对87例中的28例[32%];p = 0.037),每位患者的HF再住院率(0.22±0.54对0.46±0.76;p = 0.022)、再住院天数(1.4±4.2对3.8±8.5;p = 0.022)以及非计划就诊(65例中的14例[21%]对66例中的29例[44%];p = 0.009)。两组间血清肌酐无差异。超滤组有9例死亡,利尿剂组有11例死亡。
在失代偿性HF中,超滤比静脉利尿剂能更安全地使体重和液体丢失更多,减少HF患者90天的资源利用,是一种有效的替代治疗方法。(UNLOAD试验;http://clinicaltrials.gov/ct/show/NCT00124137?order=1;NCT00124137)