Low-dose dopamine or low-dose nesiritide in acute heart failure with renal dysfunction: the ROSE acute heart failure randomized trial.
Low-dose dopamine or low-dose nesiritide in acute heart failure with renal dysfunction: the ROSE acute heart failure randomized trial.
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DOI：
10.1001/jama.2013.282190
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发表时间：
2013-12-18
影响因子：
120.7
通讯作者：
Redfield, Margaret M.
中科院分区：
文献类型：
--
作者：
Chen, Horng H.;Anstrom, Kevin J.;Givertz, Michael M.;Stevenson, Lynne W.;Semigran, Marc J.;Goldsmith, Steven R.;Bart, Bradley A.;Bull, David A.;Stehlik, Josef;LeWinter, Martin M.;Konstam, Marvin A.;Huggins, Gordon S.;Rouleau, Jean L.;O'Meara, Eileen;Tang, W. H. Wilson;Starling, Randall C.;Butler, Javed;Deswal, Anita;Felker, G. Michael;O'Connor, Christopher M.;Bonita, Raphael E.;Margulies, Kenneth B.;Cappola, Thomas P.;Ofili, Elizabeth O.;Mann, Douglas L.;Davila-Roman, Victor G.;McNulty, Steven E.;Borlaug, Barry A.;Velazquez, Eric J.;Lee, Kerry L.;Shah, Monica R.;Hernandez, Adrian F.;Braunwald, Eugene;Redfield, Margaret M.
小型研究表明，低剂量多巴胺或低剂量奈西立肽可增强急性心力衰竭和肾功能不全患者的去充血和维持肾功能；然而，这两种策略都没有经过严格的测试。为了验证两个独立的假设，当与安慰剂相比，添加：(1)低剂量多巴胺（2 ug/kg/min）；(2)低剂量奈西立肽（0.005 ug/kg/min，不给药）联合利尿剂治疗急性心衰肾功能不全患者，可增强去充血，保护肾功能。多中心、双盲、安慰剂对照随机临床试验（Renal Optimization Strategies Evaluation），纳入入院24小时内随机就诊的360例急性心衰肾功能不全患者（肾小球滤过率估计为15-60 ml/min/1.73m2）。参与者从2010年9月到2013年3月在美国和加拿大的26个地点随机抽取。参与者以开放的1:1分配比例随机分配到多巴胺或奈西立肽策略。在每种策略中，参与者以双盲、2:1的比例随机分为积极治疗组或安慰剂组。多巴胺组（n=122）和奈西立肽组（n=119）与合并安慰剂组（n=119）进行独立比较。共同主要终点包括72小时累积尿量（去充血终点）和从入组到72小时血清胱抑素c的变化（肾功能终点）。与安慰剂相比，低剂量多巴胺对72小时累积尿量没有显著影响（多巴胺组8524 ml [95% CI 7917 ~ 9131 ml]，安慰剂组8296 ml [95% CI 7762 ~ 8830 ml]， p=0.59）或胱抑素c的变化（多巴胺组0.12 mg/L [95% CI 0.06 ~ 0.18 mg/L]，安慰剂组0.11 mg/L [95% CI 0.06 ~ 0.16 mg/L], p=0.72）。同样，低剂量奈西立肽对72小时累积尿量无显著影响（奈西立肽组8574 ml [95% CI 8014 ~ 9134 ml] vs安慰剂组8296 ml [95% CI 7762 ~ 8830 ml]， p=0.49）或胱抑素- c变化（奈西立肽组0.07 mg/L [95% CI 0.01 ~ 0.13 mg/L] vs安慰剂组0.11 mg/L [95% CI 0.06 ~ 0.16 mg/L], p=0.36）。与安慰剂相比，低剂量多巴胺或低剂量奈西立肽对缓解充血、肾功能或临床结果等次要终点没有影响。在急性心力衰竭和肾功能不全的受试者中，低剂量多巴胺和低剂量奈西立肽加入利尿剂治疗后，既不能增强去充血，也不能改善肾功能。
Small studies suggest low dose dopamine or low dose nesiritide may enhance decongestion and preserve renal function in patients with acute heart failure and renal dysfunction; however, neither strategy has been rigorously tested. To test the two independent hypotheses that when compared to placebo, addition of: (1) low dose dopamine (2 ug/kg/min); or (2) low dose nesiritide (0.005 ug/kg/min without bolus) to diuretic therapy will enhance decongestion and preserve renal function in patients with acute heart failure and renal dysfunction. Multicenter, double-blind, placebo-controlled randomized clinical trial (Renal Optimization Strategies Evaluation) of 360 hospitalized participants with acute heart failure and renal dysfunction (estimated glomerular filtration rate of 15–60 ml/min/1.73m2), randomized within 24 hours of admission. Participants were randomized from September 2010 to March 2013 across 26 sites in the United States and Canada. Participants were randomized in an open, 1:1 allocation ratio to the dopamine or nesiritide strategies. Within each strategy, participants were randomized in a double-blind, 2:1 ratio to active treatment or placebo. The dopamine (n=122) and nesiritide (n=119) groups were independently compared to the pooled placebo group (n=119). Co-primary endpoints included 72-hour cumulative urine volume (decongestion endpoint) and the change in serum cystatin-C from enrollment to 72 hours (renal function endpoint). Compared to placebo, low dose dopamine had no significant effect on 72-hour cumulative urine volume (8524 ml [95% CI 7917 to 9131 ml] with dopamine vs. 8296 ml [95% CI 7762 to 8830 ml] with placebo, p=0.59) or on the change in cystatin-C (0.12 mg/L [95% CI 0.06 to 0.18 mg/L] with dopamine vs. 0.11 mg/L [95% CI 0.06 to 0.16 mg/L] with placebo, p=0.72). Similarly, low dose nesiritide had no significant effect on 72-hour cumulative urine volume (8574 ml [95% CI 8014 to 9134 ml] with nesiritide vs. 8296 ml [95% CI 7762 to 8830 ml] with placebo, p=0.49) or on the change in cystatin-C (0.07 mg/L [95% CI 0.01 to 0.13 mg/L] with nesiritide vs. 0.11 mg/L [95% CI 0.06 to 0.16 mg/L] with placebo, p=0.36). Compared to placebo, there was no effect of low dose dopamine or low dose nesiritide on secondary endpoints reflective of decongestion, renal function, or clinical outcomes. In participants with acute heart failure and renal dysfunction, neither low dose dopamine nor low dose nesiritide enhanced decongestion or improved renal function when added to diuretic therapy.
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影响因子：
39.3
作者：
Ronco C;McCullough P;Anker SD;Anand I;Aspromonte N;Bagshaw SM;Bellomo R;Berl T;Bobek I;Cruz DN;Daliento L;Davenport A;Haapio M;Hillege H;House AA;Katz N;Maisel A;Mankad S;Zanco P;Mebazaa A;Palazzuoli A;Ronco F;Shaw A;Sheinfeld G;Soni S;Vescovo G;Zamperetti N;Ponikowski P;Acute Dialysis Quality Initiative (ADQI) consensus group
通讯作者：
Acute Dialysis Quality Initiative (ADQI) consensus group
影响因子：
4.8
作者：
Hauptman, Paul J.;Swindle, Jason;Schnitzler, Mark A.
通讯作者：
Schnitzler, Mark A.
DOI：
10.1111/paa.1999.111.5.406
发表时间：
1999-09-01
期刊：
PROCEEDINGS OF THE ASSOCIATION OF AMERICAN PHYSICIANS
影响因子：
--
作者：
Chen, HH;Burnett, JC
通讯作者：
Burnett, JC
影响因子：
158.5
作者：
Massie, Barry M.;O'Connor, Christopher M.;Dittrich, Howard C.
通讯作者：
Dittrich, Howard C.
影响因子：
24
作者：
Gottlieb, Stephen S.;Stebbins, Amanda;Hernandez, Adrian F.
通讯作者：
Hernandez, Adrian F.