Costello John M, Dunbar-Masterson Carolyn, Allan Catherine K, Gauvreau Kimberlee, Newburger Jane W, McGowan Francis X, Wessel David L, Mayer John E, Salvin Joshua W, Dionne Roger E, Laussen Peter C
From the Departments of Cardiology (J.M.C., C.D.-M., C.K.A., K.G., J.W.N., R.E.D., P.C.L.), Anesthesia (F.X.M.), and Cardiac Surgery (J.E.M.), Boston Children's Hospital, Harvard Medical School, MA; and Children's National Medical Center, George Washington University, Washington, DC (D.L.W.).
Circ Heart Fail. 2014 Jul;7(4):596-604. doi: 10.1161/CIRCHEARTFAILURE.113.001312. Epub 2014 Jun 6.
We sought to determine whether empirical nesiritide or milrinone would improve the early postoperative course after Fontan surgery. We hypothesized that compared with milrinone or placebo, patients assigned to receive nesiritide would have improved early postoperative outcomes.
In a single-center, randomized, double-blinded, placebo-controlled, multi-arm parallel-group clinical trial, patients undergoing primary Fontan surgery were assigned to receive nesiritide, milrinone, or placebo. A loading dose of study drug was administered on cardiopulmonary bypass followed by a continuous infusion for ≥12 hours and ≤5 days after cardiac intensive care unit admission. The primary outcome was days alive and out of the hospital within 30 days of surgery. Secondary outcomes included measures of cardiovascular function, renal function, resource use, and adverse events. Among 106 enrolled subjects, 35, 36, and 35 were randomized to the nesiritide, milrinone, and placebo groups, respectively, and all were analyzed based on intention to treat. Demographics, patient characteristics, and operative factors were similar among treatment groups. No significant treatment group differences were found for median days alive and out of the hospital within 30 days of surgery (nesiritide, 20 [minimum to maximum, 0-24]; milrinone, 18 [0-23]; placebo, 20 [0-23]; P=0.38). Treatment groups did not significantly differ in cardiac index, arrhythmias, peak lactate, inotropic scores, urine output, duration of mechanical ventilation, intensive care or chest tube drainage, or adverse events.
Compared with placebo, empirical perioperative nesiritide or milrinone infusions are not associated with improved early clinical outcomes after Fontan surgery.
http://www.clinicaltrials.gov. Unique identifier: NCT00543309.
我们试图确定经验性使用奈西立肽或米力农是否会改善Fontan手术后的早期病程。我们假设，与米力农或安慰剂相比，接受奈西立肽治疗的患者术后早期结局会得到改善。
在一项单中心、随机、双盲、安慰剂对照、多臂平行组临床试验中，接受初次Fontan手术的患者被分配接受奈西立肽、米力农或安慰剂治疗。在体外循环期间给予研究药物负荷剂量，随后在入住心脏重症监护病房后持续输注≥12小时且≤5天。主要结局为术后30天内存活并出院的天数。次要结局包括心血管功能、肾功能、资源利用和不良事件的指标。在106名入组受试者中，分别有35、36和35人被随机分配至奈西立肽组、米力农组和安慰剂组，所有受试者均根据意向性分析进行分析。各治疗组间的人口统计学、患者特征和手术因素相似。术后30天内存活并出院的中位天数在各治疗组间无显著差异（奈西立肽组为20天[最小值至最大值，0 - 24天]；米力农组为18天[0 - 23天]；安慰剂组为20天[0 - 23天]；P = 0.38）。各治疗组在心脏指数、心律失常、乳酸峰值、肌力评分、尿量、机械通气时间、重症监护或胸管引流时间或不良事件方面无显著差异。
与安慰剂相比，Fontan手术后经验性围手术期输注奈西立肽或米力农与早期临床结局改善无关。
