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成人体外循环中脂多糖吸附器:一项单中心随机对照试验。

A lipopolysaccharide adsorber in adult cardiopulmonary bypass: a single centre randomised controlled pilot trial.

作者信息

De Silva Ravi J, Armstrong Johanna, Bottrill Fiona, Goldsmith Kimberley, Colah Simon, Vuylsteke Alain

机构信息

Department of Anaesthesia and Intensive Care, Papworth Hospital NHS Foundation Trust, Papworth Everard, Cambridge CB23 3RE, UK.

出版信息

Interact Cardiovasc Thorac Surg. 2010 Jul;11(1):86-92. doi: 10.1510/icvts.2010.233304. Epub 2010 Apr 12.

DOI:10.1510/icvts.2010.233304
PMID:20385666
Abstract

OBJECTIVES

The aim of this study was to describe the biochemical effects and safety of selective removal of endotoxin from whole blood using a lipopolysaccharide adsorber during complex cardiac surgery.

METHODS

We carried out a single centre prospective randomised controlled pilot trial in patients undergoing elective cardiac surgery using cardiopulmonary bypass (CPB) at a large UK cardiothoracic institution. Seventeen patients were randomly allocated to one of two groups: with or without an adsorber included in the CPB circuit. Fourteen patients were included in a complete case analysis. Blood samples were taken at the time of consent, immediately following anaesthesia, at 60, 180 and 360 min after the institution of CPB, and the morning following surgery. Primary outcomes were plasma levels of endotoxin, IL-6, IL-8 and TNF-alpha. Secondary outcomes were measures of patient safety including blood chemistry and coagulation parameters, length of stay, and adverse events.

RESULTS

No differences were seen in endotoxin or cytokine levels between adsorber and control groups at any of the measured time-points. No difference between groups was detected in measures of patient safety following the intervention. Haemoglobin and haematocrit were significantly lower in the intervention group pre-bypass, P=0.02 in both instances.

CONCLUSION

There was no effect of the adsorber on endotoxin levels or inflammatory response in this study, we have demonstrated the device to be safe in a complex cardiac surgery setting.

摘要

目的

本研究旨在描述在复杂心脏手术期间使用脂多糖吸附器从全血中选择性去除内毒素的生化效应和安全性。

方法

我们在英国一家大型心胸机构对接受择期心脏手术并使用体外循环(CPB)的患者进行了一项单中心前瞻性随机对照试验。17名患者被随机分配到两组中的一组:CPB回路中包含或不包含吸附器。14名患者纳入完整病例分析。在获得同意时、麻醉后立即、CPB开始后60、180和360分钟以及术后早晨采集血样。主要结局是血浆内毒素、IL-6、IL-8和TNF-α水平。次要结局是患者安全性指标,包括血液化学和凝血参数、住院时间及不良事件。

结果

在任何测量时间点,吸附器组和对照组在内毒素或细胞因子水平上均未观察到差异。干预后两组在患者安全性指标上未检测到差异。旁路前干预组的血红蛋白和血细胞比容显著更低,两者P值均为0.02。

结论

本研究中吸附器对内毒素水平或炎症反应无影响,我们已证明该装置在复杂心脏手术环境中是安全的。

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