Effect of Fenoldopam on Use of Renal Replacement Therapy Among Patients With Acute Kidney Injury After Cardiac Surgery A Randomized Clinical Trial

被引：113

作者：

Bove, Tiziana ^{[1
]}

Zangrillo, Alberto ^{[1
,19
]}

Guarracino, Fabio ^{[2
]}

Alvaro, Gabriele ^{[3
]}

Persi, Bruno ^{[4
]}

Maglioni, Enivarco ^{[5
]}

Galdieri, Nicola ^{[6
]}

Comis, Marco ^{[7
]}

Caramelli, Fabio ^{[8
]}

Pasero, Daniela C. ^{[9
]}

Pala, Giovanni ^{[10
]}

Renzini, Massimo ^{[11
]}

Conte, Massimiliano ^{[12
]}

Paternoster, Gianluca ^{[13
]}

Martinez, Blanca ^{[14
]}

Pinelli, Fulvio ^{[15
]}

Frontini, Mario ^{[16
]}

Zucchetti, Maria C. ^{[17
]}

Pappalardo, Federico ^{[1
]}

Amantea, Bruno ^{[3
]}

Camata, Annamaria ^{[4
]}

Pisano, Antonio ^{[6
]}

Verdecchia, Claudio ^{[7
]}

Dal Checco, Erika ^{[8
]}

Cariello, Claudia ^{[2
]}

Faita, Luana ^{[3
]}

Baldassarri, Rubia ^{[2
]}

Scandroglio, Anna M. ^{[1
]}

Saleh, Omar ^{[1
]}

Lembo, Rosalba ^{[1
]}

Calabro, Maria G. ^{[1
]}

Bellomo, Rinaldo ^{[18
]}

Landoni, Giovanni ^{[1
,19
]}

机构：

[1] IRCCS San Raffaele Sci Inst, I-20132 Milan, Italy

[2] Univ Hosp Pisa, Pisa, Italy

[3] Mater Domini Hosp, Catanzaro, Italy

[4] Osped Civile Ca Foncello Treviso, Treviso, Italy

[5] Siena Hosp, Siena, Italy

[6] Monaldi Hosp, AORN Dei Colli, Naples, Italy

[7] Molinette Mauriziano Hosp, Turin, Italy

[8] S Orsola Malpighi Univ Hosp, Bologna, Italy

[9] Univ Turin, Citta Salute & Sci Hosp, Turin, Italy

[10] Osped Civile SS Annunziata, Sassari, Italy

[11] Osped Santa Maria Misericordia, Perugia, Italy

[12] Cotignola & Citta Lecce Hosp, Maria Cecilia Hosp GVM Care & Res, Lecce, Italy

[13] AO Reg San Carlo, Potenza, Italy

[14] Santa Maria Misericordia Univ Hosp Udine, Udine, Italy

[15] Careggi Univ Hosp, Florence, Italy

[16] AO Spedali Civili Brescia, Brescia, Italy

[17] AO Osped Riuniti Papardo Piemonte, Messina, Italy

[18] Monash Univ, Sch Publ Hlth & Prevent Med, Australian & New Zealand Intens Care Res Ctr, Melbourne, Vic 3004, Australia

[19] Univ Vita Salute San Raffaele, Milan, Italy

来源：

JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION | 2014年 / 312卷 / 21期

关键词：

CRITICALLY-ILL PATIENTS; DOUBLE-BLIND; FAILURE; RISK; MORTALITY; PROTECTION; INFUSION; DIALYSIS; NEED;

D O I：

10.1001/jama.2014.13573

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

IMPORTANCE No effective pharmaceutical agents have yet been identified to treat acute kidney injury after cardiac surgery. OBJECTIVE To determine whether fenoldopam reduces the need for renal replacement therapy in critically ill cardiac surgery patients with acute kidney injury. DESIGN, SETTING, AND PARTICIPANTS Multicenter, randomized, double-blind, placebo-controlled, parallel-group study from March 2008 to April 2013 in 19 cardiovascular intensive care units in Italy. We randomly assigned 667 patients admitted to intensive care units after cardiac surgery with early acute kidney injury (>= 50% increase of serum creatinine level from baseline or oliguria for >= 6 hours) to receive fenoldopam (338 patients) or placebo (329 patients). We used a computer-generated permuted block randomization sequence for treatment allocation. All patients completed their follow-up 30 days after surgery, and data were analyzed according to the intention-to-treat principle. INTERVENTIONS Continuous infusion of fenoldopam or placebo for up to 4 days with a starting dose of 0.1 mu g/kg/min (range, 0.025-0.3 mu g/kg/min). MAIN OUTCOMES AND MEASURES The primary end point was the rate of renal replacement therapy. Secondary end points included mortality (intensive care unit and 30-day mortality) and the rate of hypotension during study drug infusion. RESULTS The study was stopped for futility as recommended by the safety committee after a planned interim analysis. Sixty-nine of 338 patients (20%) allocated to the fenoldopam group and 60 of 329 patients (18%) allocated to the placebo group received renal replacement therapy (P = .47). Mortality at 30 days was 78 of 338 (23%) in the fenoldopam group and 74 of 329 (22%) in the placebo group (P = .86). Hypotension occurred in 85 (26%) patients in the fenoldopam group and in 49 (15%) patients in the placebo group (P = .001). CONCLUSIONS AND RELEVANCE Among patients with acute kidney injury after cardiac surgery, fenoldopam infusion, compared with placebo, did not reduce the need for renal replacement therapy or risk of 30-day mortality but was associated with an increased rate of hypotension.

引用

页码：2244 / 2253

页数：10

共 35 条

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