高危患者群体小儿心脏手术后的严格血糖控制：心脏手术后安全的小儿正常血糖试验的二次分析
Tight glycemic control after pediatric cardiac surgery in high-risk patient populations: a secondary analysis of the safe pediatric euglycemia after cardiac surgery trial.
作者信息
Agus Michael S D, Asaro Lisa A, Steil Garry M, Alexander Jamin L, Silverman Melanie, Wypij David, Gaies Michael G
机构信息
From the Division of Medicine Critical Care (M.S.D.A., G.M.S., J.L.A., M.S.) and Department of Cardiology (L.A.A., D.W.), Boston Children's Hospital and Harvard Medical School, Boston, MA; Department of Biostatistics, Harvard School of Public Health, Boston, MA (D.W.); and Division of Pediatric Cardiology, C.S. Mott Children's Hospital and University of Michigan Medical School, Ann Arbor (M.G.G.).
出版信息
Circulation. 2014 Jun 3;129(22):2297-304. doi: 10.1161/CIRCULATIONAHA.113.008124. Epub 2014 Mar 26.
BACKGROUND
Our previous randomized, clinical trial showed that postoperative tight glycemic control (TGC) for children undergoing cardiac surgery did not reduce the rate of health care-associated infections compared with standard care (STD). Heterogeneity of treatment effect may exist within this population.
METHODS AND RESULTS
We performed a post hoc exploratory analysis of 980 children from birth to 36 months of age at the time of cardiac surgery who were randomized to postoperative TGC or STD in the intensive care unit. Significant interactions were observed between treatment group and both neonate (age ≤30 days; P=0.03) and intraoperative glucocorticoid exposure (P=0.03) on the risk of infection. The rate and incidence of infections in subjects ≤60 days old were significantly increased in the TGC compared with the STD group (rate: 13.5 versus 3.7 infections per 1000 cardiac intensive care unit days, P=0.01; incidence: 13% versus 4%, P=0.02), whereas infections among those >60 days of age were significantly reduced in the TGC compared with the STD group (rate: 5.0 versus 14.1 infections per 1000 cardiac intensive care unit days, P=0.02; incidence: 2% versus 5%, P=0.03); the interaction of treatment group by age subgroup was highly significant (P=0.001). Multivariable logistic regression controlling for the main effects revealed that previous cardiac surgery, chromosomal anomaly, and delayed sternal closure were independently associated with increased risk of infection.
CONCLUSIONS
This exploratory analysis demonstrated that TGC may lower the risk of infection in children >60 days of age at the time of cardiac surgery compared with children receiving STD. Meta-analyses of past and ongoing clinical trials are necessary to confirm these findings before clinical practice is altered.
CLINICAL TRIAL REGISTRATION URL
http://www.clinicaltrials.gov. Unique identifier: NCT00443599.
背景
我们之前的随机临床试验表明，与标准治疗（STD）相比，接受心脏手术的儿童术后严格血糖控制（TGC）并未降低医疗相关感染率。该人群中可能存在治疗效果的异质性。
方法与结果
我们对980例心脏手术时年龄从出生到36个月的儿童进行了事后探索性分析，这些儿童在重症监护病房被随机分为术后TGC组或STD组。在治疗组与新生儿（年龄≤30天；P = 0.03）以及术中糖皮质激素暴露（P = 0.03）之间观察到感染风险存在显著交互作用。与STD组相比，TGC组中≤60日龄受试者的感染率和感染发生率显著增加（感染率：每1000个心脏重症监护病房日13.5例感染对3.7例感染，P = 0.01；感染发生率：13%对4%，P = 0.02），而与STD组相比，TGC组中>60日龄儿童的感染显著减少（感染率：每1000个心脏重症监护病房日5.0例感染对14.1例感染，P = 0.02；感染发生率：2%对5%，P = 0.03）；治疗组与年龄亚组之间的交互作用非常显著（P = 0.001）。控制主要效应的多变量逻辑回归显示，既往心脏手术、染色体异常和胸骨延迟闭合与感染风险增加独立相关。
结论
这项探索性分析表明，与接受STD治疗的儿童相比，TGC可能降低心脏手术时>60日龄儿童的感染风险。在改变临床实践之前，有必要对过去和正在进行的临床试验进行荟萃分析以证实这些发现。
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