Ethical considerations in conducting surgical research in severe complicated intra-abdominal sepsis

World Journal of Emergency Surgery

卷:14

the Closed Or Open after Laparotomy (COOL) after Source Control for Severe Complicated Intra-Abdominal Sepsis Investigators¹  Matti Tolonen²  Stacey A Page³  Christopher J. Doig⁴  Andrew W. Kirkpatrick⁵  Sam F. Minor⁶  Jose J Diaz⁷  Fikri M. Abu-Zidan⁸  Massimo Sartelli⁹  Bruno M. Peirera¹⁰  Fausto Catena¹¹  Federico Coccolini¹²  John C. Marshall¹³  Jessica L. McKee¹⁴  Peter D Faris¹⁵  Rosemary Carroll¹⁶  Luca Ansaloni¹⁷  Ernest E. Moore¹⁸ 

[1] ;

[2] Department of Abdominal Surgery, Abdominal Center, University of Helsinki and Helsinki University Central Hospital;

[3] Department of Community Health Sciences, Cumming School of Medicine, University of Calgary;

[4] Department of Critical Care Medicine, Cumming School of Medicine, University of Calgary;

[5] Department of Critical Care Medicine, University of Calgary;

[6] Department of Critical Care and Department of Surgery, NSHA- Queen Elizabeth II Health Sciences Centre;

[7] Department of Surgery, Acute Care Surgery, R Adams Cowley Shock Trauma Center, University of Maryland School on Medicine;

[8] Department of Surgery, College of Medicine and Health Sciences, UAE University;

[9] Department of Surgery, Macerata Hospital;

[10] Division of Trauma Surgery, University of Campinas;

[11] Emergency Surgery Department, Parma University Hospital;

[12] General, Emergency and Trauma Surgery dept, Bufalini Hospital;

[13] Li Ka Shing Knowledge Institute, St. Michael’s Hospital, University of Toronto;

[14] Regional Trauma Services, Foothills Medical Centre;

[15] Research Facilitation Analytics (DIMR), University of Calgary;

[16] Surgical Services John Hunter Hospital;

[17] Unit of General and Emergency Surgery, Bufalini Hospital of Cesena;

[18] University of Colorado;

关键词: Intra-peritoneal sepsis;    Open-abdomen;    Randomized controlled trial;    Multiple organ dysfunction;    Consent;    Waiver;   

DOI  :  10.1186/s13017-019-0259-9

来源: DOAJ

【 摘 要 】

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 (https://clinicaltrials.gov/ct2/show/NCT03163095) 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.

【 授权许可】

Unknown