Closed Or Open after Source Control Laparotomy for Severe Complicated Intra-Abdominal Sepsis (the COOL trial): study protocol for a randomized ... View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2018-06-22

AUTHORS

Andrew W. Kirkpatrick, Federico Coccolini, Luca Ansaloni, Derek J. Roberts, Matti Tolonen, Jessica L. McKee, Ari Leppaniemi, Peter Faris, Christopher J. Doig, Fausto Catena, Timothy Fabian, Craig N. Jenne, Osvaldo Chiara, Paul Kubes, Braden Manns, Yoram Kluger, Gustavo P. Fraga, Bruno M. Pereira, Jose J. Diaz, Michael Sugrue, Ernest E. Moore, Jianan Ren, Chad G. Ball, Raul Coimbra, Zsolt J. Balogh, Fikri M. Abu-Zidan, Elijah Dixon, Walter Biffl, Anthony MacLean, Ian Ball, John Drover, Paul B. McBeth, Juan G. Posadas-Calleja, Neil G. Parry, Salomone Di Saverio, Carlos A. Ordonez, Jimmy Xiao, Massimo Sartelli,

ABSTRACT

Background: Severe complicated intra-abdominal sepsis (SCIAS) has an increasing incidence with mortality rates over 80% in some settings. Mortality typically results from disruption of the gastrointestinal tract, progressive and self-perpetuating bio-mediator generation, systemic inflammation, and multiple organ failure. Principles of treatment include early antibiotic administration and operative source control. A further therapeutic option may be open abdomen (OA) management with active negative peritoneal pressure therapy (ANPPT) to remove inflammatory ascites and ameliorate the systemic damage from SCIAS. Although there is now a biologic rationale for such an intervention as well as non-standardized and erratic clinical utilization, this remains a novel therapy with potential side effects and clinical equipoise. Methods: The Closed Or Open after Laparotomy (COOL) study will constitute a prospective randomized controlled trial that will randomly allocate eligible surgical patients intra-operatively to either formal closure of the fascia or use of the OA with application of an ANPTT dressing. Patients will be eligible if they have free uncontained intra-peritoneal contamination and physiologic derangements exemplified by septic shock OR a Predisposition-Infection-Response-Organ Dysfunction Score ≥ 3 or a World-Society-of-Emergency-Surgery-Sepsis-Severity-Score ≥ 8. The primary outcome will be 90-day survival. Secondary outcomes will be logistical, physiologic, safety, bio-mediators, microbiological, quality of life, and health-care costs. Secondary outcomes will include days free of ICU, ventilation, renal replacement therapy, and hospital at 30 days from the index laparotomy. Physiologic secondary outcomes will include changes in intensive care unit illness severity scores after laparotomy. Bio-mediator outcomes for participating centers will involve measurement of interleukin (IL)-6 and IL-10, procalcitonin, activated protein C (APC), high-mobility group box protein-1, complement factors, and mitochondrial DNA. Economic outcomes will comprise standard costing for utilization of health-care resources. Discussion: Although facial closure after SCIAS is considered the current standard of care, many reports are suggesting that OA management may improve outcomes in these patients. This trial will be powered to demonstrate a mortality difference in this highly lethal and morbid condition to ensure critically ill patients are receiving the best care possible and not being harmed by inappropriate therapies based on opinion only. Trial registration: ClinicalTrials.gov, NCT03163095. More... »

PAGES

26

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  • Journal

    TITLE

    World Journal of Emergency Surgery

    ISSUE

    1

    VOLUME

    13

    Author Affiliations

  • The Trauma Program, University of Calgary, Calgary, Alberta Canada
  • General, Emergency and Trauma Surgery Department, Bufalini Hospital, Cesena, Italy
  • Unit of General and Emergency Surgery, Bufalini Hospital of Cesena, Cesena, Italy
  • Department of Surgery, University of Calgary, Calgary, Alberta Canada
  • Department of Abdominal Surgery, Abdominal Center, University of Helsinki and Helsinki University Central Hospital, Helsinki, Finland
  • Regional Trauma Services, Foothills Medical Centre, Calgary, Alberta Canada
  • Research Facilitation Analytics (DIMR), University of Calgary, Calgary, Alberta Canada
  • Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta Canada
  • Emergency Surgery Department, Parma University Hospital, Parma, Italy
  • Surgery, University of Tennessee Health Sciences Center Memphis, Memphis, TN USA
  • Department of Critical Care Medicine, University of Calgary, Calgary, Alberta Canada
  • General Surgery and Trauma Team Niguarda Hospital Milano, Milan, Italy
  • Department of Pharmacology, Cumming School of Medicine, University of Calgary, Calgary, Alberta Canada
  • Libin Cardiovascular Institute and O’Brien Institute of Public Health, University of Calgary, Calgary, Alberta Canada
  • Rambam Health Care Campus, Haifa, Israel
  • Division of Trauma Surgery, University of Campinas, Campinas, SP Brazil
  • Department of Surgery, R Adams Cowley Shock Trauma Center, University of Maryland School on Medicine, Baltimore, MD USA
  • Donegal Clinical Research Academy, Letterkenny University Hospital, Donegal, Ireland
  • Trauma and Critical Care Research, University of Colorado, Denver, CO USA
  • Department of Surgery, Jinling Hospital, Medical School of Nanjing University, Nanjing, China
  • General, Acute Care, and Hepatobiliary Surgery, and Regional Trauma Services, University of Calgary, Calgary, Alberta Canada
  • Department of Surgery, Loma Linda University School of Medicine, Loma Linda, CA USA
  • Surgery and Traumatology, University of Newcastle, Newcastle, NSW Australia
  • Department of Surgery, College of Medicine and Health Sciences, UAE University, Al-Ain, United Arab Emirates
  • City Wide Section of General Surgery, University of Calgary, Calgary, Alberta Canada
  • Scripps Memorial Hospital La Jolla, La Jolla, California USA
  • Department of Epidemiology and Biostatistics, Western University, London, Ontario Canada
  • Department of Surgery, Queen’s University, Kingston, Ontario Canada
  • Department of Critical Care, Western University, Victoria Hospital, London Health Sciences Centre, London, Ontario Canada
  • Addenbrooke’s Hospital, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK
  • Department of Surgery, Fundación Valle del Lili and Universidad Del Valle, Cali, Colombia
  • Department of Surgery, Macerata Hospital, Macerata, Italy
  • Identifiers

    URI

    http://scigraph.springernature.com/pub.10.1186/s13017-018-0183-4

    DOI

    http://dx.doi.org/10.1186/s13017-018-0183-4

    DIMENSIONS

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    PUBMED

    https://www.ncbi.nlm.nih.gov/pubmed/29977328


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