title: Consensus statement: minimal criteria for reporting the systemic inflammatory response to cardiopulmonary bypass.
abstract: The lack of established cause and effect between putative mediators of inflammation and adverse clinical outcomes has been responsible for many failed anti-inflammatory interventions in cardiopulmonary bypass (CPB). Candidate interventions that impress in preclinical trials by suppressing a given inflammation marker might fail at the clinical trial stage because the marker of interest is not linked causally to an adverse outcome. Alternatively, there exist examples in which pharmaceutical agents or other interventions improve clinical outcomes but for which we are uncertain of any antiinflammatory mechanism. The Outcomes consensus panel made 3 recommendations in 2009 for the conduct of clinical trials focused on the systemic inflammatory response. This panel was tasked with updating, as well as simplifying, a previous consensus statement. The present recommendations for investigators are the following: (1) Measure at least 1 inflammation marker, defined in broad terms; (2) measure at least 1clinical end point, drawn from a list of practical yet clinically meaningful end points suggested by the consensus panel; and(3) report a core set of CPB and perfusion criteria that maybe linked to outcomes. Our collective belief is that adhering to these simple consensus recommendations will help define the influence of CPB practice on the systemic inflammatory response, advance our understanding of causal inflammatory mechanisms, and standardize the reporting of research findings in the peer-reviewed literature.
authors.affiliation: University of the West Indies, Bridgetown, Barbados. clive.landis@cavehill.uwi.edu
authors.forename: R
authors.initials: R
authors.lastname: Clive Landis
authors.forename: John M
authors.initials: JM
authors.lastname: Murkin
authors.forename: David A
authors.initials: DA
authors.lastname: Stump
authors.forename: Robert A
authors.initials: RA
authors.lastname: Baker
authors.forename: Joseph E
authors.initials: JE
authors.lastname: Arrowsmith
authors.forename: Filip
authors.initials: F
authors.lastname: De Somer
authors.forename: Steven L
authors.initials: SL
authors.lastname: Dain
authors.forename: Wojciech B
authors.initials: WB
authors.lastname: Dobkowski
authors.forename: John E
authors.initials: JE
authors.lastname: Ellis
authors.forename: Florian
authors.initials: F
authors.lastname: Falter
authors.forename: Gregory
authors.initials: G
authors.lastname: Fischer
authors.forename: John W
authors.initials: JW
authors.lastname: Hammon
authors.forename: Richard A
authors.initials: RA
authors.lastname: Jonas
authors.forename: Robert S
authors.initials: RS
authors.lastname: Kramer
authors.forename: Donald S
authors.initials: DS
authors.lastname: Likosky
authors.forename: F
authors.initials: F
authors.lastname: Paget Milsom
authors.forename: Michael
authors.initials: M
authors.lastname: Poullis
authors.forename: Edward D
authors.initials: ED
authors.lastname: Verrier
authors.forename: Keith
authors.initials: K
authors.lastname: Walley
authors.forename: Stephen
authors.initials: S
authors.lastname: Westaby
mesh_terms: D002309:Cardiology / Q000592:standards*; D002315:Cardiopulmonary Bypass; D006801:Humans; D007249:Inflammation / Q000175:diagnosis* / Q000209:etiology; D019221:Mandatory Reporting; D017410:Practice Guidelines as Topic