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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

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
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
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
1-9
Isset, Richard
a884aee5-8096-4ee3-97d4-850f5d06e387
Sheppard, Stuart
7d9513e1-2275-4c2b-b0f1-9a32ee4f37c0
Voegeli, David
e6f5d112-55b0-40c1-a6ad-8929a2d84a10
Walsh, Bronagh
5818243e-048d-4b4b-88c5-231b0e419427
Isset, Richard
a884aee5-8096-4ee3-97d4-850f5d06e387
Sheppard, Stuart
7d9513e1-2275-4c2b-b0f1-9a32ee4f37c0
Voegeli, David
e6f5d112-55b0-40c1-a6ad-8929a2d84a10
Walsh, Bronagh
5818243e-048d-4b4b-88c5-231b0e419427

Isset, Richard, Sheppard, Stuart, Voegeli, David and Walsh, Bronagh (2013) 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. Working Papers in the Health Sciences, 1 (6), Winter Issue, 1-9.

Record type: Article

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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Published date: 2013
Organisations: Faculty of Health Sciences

Identifiers

Local EPrints ID: 386628
URI: http://eprints.soton.ac.uk/id/eprint/386628
PURE UUID: 048cd37e-1000-4904-ad4c-f2bdc7d89e7f
ORCID for David Voegeli: ORCID iD orcid.org/0000-0003-3457-7177
ORCID for Bronagh Walsh: ORCID iD orcid.org/0000-0003-1008-0545

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Date deposited: 02 Feb 2016 16:44
Last modified: 15 Jul 2020 00:26

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Contributors

Author: Richard Isset
Author: Stuart Sheppard
Author: David Voegeli ORCID iD
Author: Bronagh Walsh ORCID iD

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