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Type: Artigo
Title: Ethical considerations in conducting surgical research in severe complicated intra-abdominal sepsis
Author: Page, Stacey A.
McKee, Jessica L.
Moore, Ernest E.
Abu-Zidan, Fikri M.
Carroll, Rosemary
Marshall, John C.
Faris, Peter D.
Tolonen, Matti
Catena, Fausto
Cocolini, Federico
Sartelli, Massimo
Ansaloni, Luca
Minor, Sam F.
Peirera, Bruno M.
Diaz, Jose J.
Kirkpatrick, Andrew W.
Roberts, Derek J.
Leppaniemi, Ari
Jenne, Craig N.
Chiara, Osvaldo
Kubes, Paul
Manns, Braden
Kluger, Yoram
Fraga, Gustavo P.
Pereira, Bruno M.
Sugrue, Michael
Holm, Teresa
Ren, Jianan
Ball, Chad G.
Coimbra Raul
Balogh, Zsolt J.
Dixon, Elijah
Biffl, Walter
MacLean, Anthony
Ball, Ian
Drover, John W.
McBeth, Paul B.
Posadas-Calleja, Juan G.
Parry, Neil G.
Saverio, Salomone Di
Ordonez, Carlos A.
Bendinelli, Cino
MacDonald, Bradeon
Dunham, Michael
Reso, Artan
Vogt, Kelly N.
Blaser, Annika Reintam
Malbrain, Manu
Tartaglia, Dario
Waele, Jan De
Dubuisson, Vincent
Lampela, Hanna
Bodnar, Zsolt
Isik, Arda
Picetti, Edoardo
Hameed, Morad
Garraway, Naisan R.
Julien, Lisa
Widder, Sandy
Bradley, Norie L.
Engels, Paul T.
Leeper, W. Robert
Beckett, Andrew
Coimbra, Raul
Leeper , W. Robert
Beckett , Andrew
Abstract: Background Severe complicated intra-abdominal sepsis (SCIAS) has high mortality, thought due in part to progressive bio-mediator generation, systemic inflammation, and multiple organ failure. Treatment includes early antibiotics and operative source control. At surgery, open abdomen management with negative-peritoneal-pressure therapy (NPPT) has been hypothesized to mitigate MOF and death, although clinical equipoise for this operative approach exists. The Closed or Open after Laparotomy (COOL) study () will prospectively randomize eligible patients intra-operatively to formal abdominal closure or OA with NPTT. We review the ethical basis for conducting research in SCIAS. Main body Research in critically ill incapacitated patients is important to advance care. Conducting research among SCIAS is complicated due to the severity of illness including delirium, need for emergent interventions, diagnostic criteria confirmed only at laparotomy, and obtundation from anaesthesia. In other circumstances involving critically ill patients, clinical experts have worked closely with ethicists to apply principles that balance the rights of patients whilst simultaneously permitting inclusion in research. In Canada, the Tri-Council Policy Statement-2 (TCPS-2) describes six criteria that permit study enrollment and randomization in such situations: (a) serious threat to the prospective participant requires immediate intervention; (b) either no standard efficacious care exists or the research offers realistic possibility of direct benefit; (c) risks are not greater than that involved in standard care or are clearly justified by prospect for direct benefits; (d) prospective participant is unconscious or lacks capacity to understand the complexities of the research; (e) third-party authorization cannot be secured in sufficient time; and (f) no relevant prior directives are known to exist that preclude participation. TCPS-2 criteria are in principle not dissimilar to other (inter)national criteria. The COOL study will use waiver of consent to initiate enrollment and randomization, followed by surrogate or proxy consent, and finally delayed informed consent in subjects that survive and regain capacity. Conclusions A delayed consent mechanism is a practical and ethical solution to challenges in research in SCIAS. The ultimate goal of consent is to balance respect for patient participants and to permit participation in new trials with a reasonable opportunity for improved outcome and minimal risk of harm
Subject: Falência de multiplos orgãos
Ensaio clínico controlado aleatório
Country: Reino Unido
Editor: Springer Nature
Rights: Aberto
Identifier DOI: 10.1186/s13017-019-0259-9
Date Issue: 2019
Appears in Collections:FCM - Artigos e Outros Documentos

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