Design of a prospective clinical study on the quantification of lipid and leucocyte filtration and the effects on cerebral and renal injury markers and pulmonary function during cardiopulmonary bypass

Abstract

Background: Neurological complications are common following cardiothoracic surgery using cardiopulmonary bypass; these can range from episodes of temporary delirium to severely debilitating strokes. Despite strong evidence showing the involvement of lipid microemboli, there is currently no established method for the effective removal of these particles. We conceived the study described here to evaluate the clinical use of a new integral lipid filter in reducing lipid microemboli and to determine the impact on markers of cerebral and renal injury and pulmonary dysfunction during the cardiopulmonary bypass period.

Methods/Design: Fifty patients undergoing routine coronary artery bypass grafting using cardiopulmonary bypass will be randomised to either the intervention group, receiving the integral lipid filter during surgery, or a control group which does not. All clinicians and patients will be blinded as to their method of treatment. Measurements of lipid emboli will be taken throughout the surgical period with biochemical markers measured throughout the surgical and postoperative period.

Discussion: Limited success has been found in removing lipid microemboli using currently available methods. An integral lipid filter may well fulfill this role and help reduce the associated morbidity. This paper reports the design and methods for a randomized controlled trial comparing the outcomes of the RemoweLL lipid and leucocyte removing filter with standard equipment for patients undergoing coronary artery bypass grafting using cardiopulmonary bypass.

Trial registration: International Standard Randomised Controlled Trial Number Register: ISRCTN56462370
EudraCT Number: 2009-011503-23

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Identifiers

ORCID for David Voegeli: orcid.org/0000-0003-3457-7177

ORCID for Bronagh Walsh: orcid.org/0000-0003-1008-0545

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