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

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.