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


CONCLUSIONS
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.
De Silva
Ravi J
RJ
Department of Anaesthesia and Intensive Care, Papworth Hospital NHS Foundation Trust, Papworth Everard, Cambridge CB23 3RE, UK.
Armstrong
Johanna
J
Bottrill
Fiona
F
Goldsmith
Kimberley
K
Colah
Simon
S
Vuylsteke
Alain
A
D000327:Adsorption; D000368:Aged; D000369:Aged, 80 and over; D001777:Blood Coagulation; D006348:Cardiac Surgical Procedures / Q000009:adverse effects; D002315:Cardiopulmonary Bypass / Q000009:adverse effects; D017558:Elective Surgical Procedures; D004731:Endotoxins / Q000097:blood; D004739:England; D004867:Equipment Design; D005112:Extracorporeal Circulation / Q000009:adverse effects / Q000295:instrumentation*; D005260:Female; D006801:Humans; D007249:Inflammation / Q000097:blood / Q000209:etiology / Q000517:prevention & control*; D018836:Inflammation Mediators / Q000097:blood; D015850:Interleukin-6 / Q000097:blood; D016209:Interleukin-8 / Q000097:blood; D007902:Length of Stay; D008070:Lipopolysaccharides / Q000097:blood*; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011446:Prospective Studies; D013997:Time Factors; D016896:Treatment Outcome; D014409:Tumor Necrosis Factor-alpha / Q000097:blood
C508606:CXCL8 protein, human; D004731:Endotoxins; C508600:IL6 protein, human; D018836:Inflammation Mediators; D015850:Interleukin-6; D016209:Interleukin-8; D008070:Lipopolysaccharides; D014409:Tumor Necrosis Factor-alpha