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

World Journal of Emergency Surgery

Yoram Kluger¹  for The Closed Or Open after Laparotomy (COOL) after Source Control for Severe Complicated Intra-Abdominal Sepsis Investigators¹  Salomone Di Saverio²  Paul Kubes³  Matti Tolonen⁴  Ari Leppaniemi⁴  John Drover⁵  Christopher J. Doig⁶  Craig N. Jenne⁶  Juan G. Posadas-Calleja⁶  Ian Ball⁷  Fikri M. Abu-Zidan⁸  Carlos A. Ordonez⁹  Jianan Ren^1,10  Massimo Sartelli^1,11  Jose J. Diaz^1,12  Paul B. McBeth^1,13  Andrew W. Kirkpatrick^1,13  Anthony MacLean^1,13  Elijah Dixon^1,13  Derek J. Roberts^1,13  Neil G. Parry^1,14  Bruno M. Pereira^1,15  Gustavo P. Fraga^1,15  Michael Sugrue^1,16  Braden Manns^1,17  Fausto Catena^1,17  Osvaldo Chiara^1,18  Chad G. Ball^1,19  Federico Coccolini^2,20  Zsolt J. Balogh^2,21  Jessica L. McKee^2,22  Jimmy Xiao^2,22  Peter Faris^2,23  Raul Coimbra^2,24  Walter Biffl^2,25  Timothy Fabian^2,26  Ernest E. Moore^2,27  Luca Ansaloni^2,28 

[1] ;Addenbrooke’s Hospital, Cambridge University Hospitals NHS Foundation Trust;Calvin, Phoebe and Joan Snyder Institute for Chronic Diseases, University of Calgary;Department of Abdominal Surgery, Abdominal Center, University of Helsinki and Helsinki University Central Hospital;Department of Critical Care Medicine, Queen’s University;Department of Critical Care Medicine, University of Calgary;Department of Medicine, Western University;Department of Surgery, College of Medicine and Health Sciences, UAE University;Department of Surgery, Fundación Valle del Lili and Universidad Del Valle;Department of Surgery, Jinling Hospital, Medical School of Nanjing University;Department of Surgery, Macerata Hospital;Department of Surgery, R Adams Cowley Shock Trauma Center, University of Maryland School on Medicine;Department of Surgery, University of Calgary;Department of Surgery, Western University, Victoria Hospital, London Health Sciences Centre;Division of Trauma Surgery, University of Campinas;Donegal Clinical Research Academy, Letterkenny University Hospital;Emergency Surgery Department, Parma University Hospital;General Surgery and Trauma Team Niguarda Hospital Milano;General, Acute Care, and Hepatobiliary Surgery, and Regional Trauma Services, University of Calgary;General, Emergency and Trauma Surgery Department, Bufalini Hospital;John Hunter Hospital and Hunter New England Health District;Regional Trauma Services, Foothills Medical Centre;Research Facilitation Analytics (DIMR), University of Calgary;Riverside University Health System Medical Center;Scripps Memorial Hospital La Jolla;Surgery, University of Tennessee Health Sciences Center Memphis;Trauma and Critical Care Research, University of Colorado;Unit of General and Emergency Surgery, Bufalini Hospital of Cesena;

关键词: Intra-peritoneal sepsis;    Septic shock;    Peritonitis;    Open-abdomen;    Multiple organ dysfunction;    Laparotomy;   

DOI  :  10.1186/s13017-018-0183-4

来源: DOAJ

【 摘 要 】

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.

【 授权许可】

Unknown