A composite outcome for neonatal cardiac surgery research
A composite outcome for neonatal cardiac surgery research
复制标题
DOI：
10.1016/j.jtcvs.2013.03.013
复制
发表时间：
2014-01-01
影响因子：
6
通讯作者：
Graham, Eric M.
中科院分区：
文献类型：
--
作者：
Butts, Ryan J.;Scheurer, Mark A.;Graham, Eric M.
目的：这项研究的目的是确定心脏输出不足的客观迹象的复合结果是否与其他重要结局措施有关，因此是新生儿心脏外科临床试验的适当终点。正经历需要心肺旁路的心脏手术的新生儿（n = 76）。如果患者在出院前发生以下任何事件，则将患者定义为综合结果：死亡，使用机械循环支持，需要胸部压缩的心脏骤停，肝损伤（是天冬氨酸氨基转移酶正常上限的2倍丙氨酸氨基转移酶），肾损伤（肌酐> 1.5 mg/dl）或乳酸酸中毒（乳酸升高> 5术后时期的MMOL/L。确定了复合结果与机械通气，重症监护病房住院，住院和总医院费用之间的关联。退回：手术时的中位年龄为7天，中位体重为3.2 kg。 39％的患者（30/76）满足了综合结果。与没有机械通气时间更长的持续时间（4.9 vs 2.9天，p <.01），重症监护病房住院时间（8.8 vs 5.7天，p <.01）相比23比12天，p <.01），并增加了医院费用（258,000美元，$ 170,000，p <.01）。在线性回归分析中，控制手术复杂性，这些差异仍然显着（R-2 = 0.29-0.42，p <.01）。结论：综合结果与重要的早期手术结果高度相关对于正在进行心脏操作的新生儿的未来临床研究。
Objective: The objective of this study was to determine whether a composite outcome, derived of objective signs of inadequate cardiac output, would be associated with other important measures of outcomes and therefore be an appropriate end point for clinical trials in neonatal cardiac surgery.Methods: Neonates (n = 76) undergoing cardiac operations requiring cardiopulmonary bypass were prospectively enrolled. Patients were defined to have met the composite outcome if they had any of the following events before hospital discharge: death, the use of mechanical circulatory support, cardiac arrest requiring chest compressions, hepatic injury (2 times the upper limit of normal for aspartate aminotransferase or alanine aminotransferase), renal injury (creatinine >1.5 mg/dL), or lactic acidosis (an increasing lactate >5 mmol/L in the postoperative period). Associations between the composite outcome and the duration of mechanical ventilation, intensive care unit stay, hospital stay, and total hospital charges were determined.Results: The median age at the time of surgery was 7 days, and the median weight was 3.2 kg. The composite outcome was met in 39% of patients (30/76). Patients who met the composite outcome compared with those who did not had a longer duration of mechanical ventilation (4.9 vs 2.9 days, P < .01), intensive care unit stay (8.8 vs 5.7 days, P < .01), hospital stay (23 vs 12 days, P < .01), and increased hospital charges ($258,000 vs $170,000, P < .01). In linear regression analysis, controlling for surgical complexity, these differences remained significant (R-2 = 0.29-0.42, P < .01).Conclusions: The composite outcome is highly associated with important early operative outcomes and may serve as a useful end point for future clinical research in neonates undergoing cardiac operations.