Closed Or Open after Source Control Laparotomy for Severe Complicated Intra-Abdominal Sepsis (the COOL trial): study protocol for a randomized controlled trial
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 inflammatio...
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| Format: | Article |
| Language: | English |
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BMC
2018-06-01
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| Series: | World Journal of Emergency Surgery |
| Subjects: | |
| Online Access: | http://link.springer.com/article/10.1186/s13017-018-0183-4 |
| _version_ | 1829137095816380416 |
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| author | 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 for The Closed Or Open after Laparotomy (COOL) after Source Control for Severe Complicated Intra-Abdominal Sepsis Investigators |
| author_facet | 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 for The Closed Or Open after Laparotomy (COOL) after Source Control for Severe Complicated Intra-Abdominal Sepsis Investigators |
| author_sort | Andrew W. Kirkpatrick |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-14T18:52:53Z |
| format | Article |
| id | doaj.art-a897e9e3b105473796a2ace535e7ab1f |
| institution | Directory Open Access Journal |
| issn | 1749-7922 |
| language | English |
| last_indexed | 2024-12-14T18:52:53Z |
| publishDate | 2018-06-01 |
| publisher | BMC |
| record_format | Article |
| series | World Journal of Emergency Surgery |
| spelling | doaj.art-a897e9e3b105473796a2ace535e7ab1f2022-12-21T22:51:12ZengBMCWorld Journal of Emergency Surgery1749-79222018-06-0113111610.1186/s13017-018-0183-4Closed Or Open after Source Control Laparotomy for Severe Complicated Intra-Abdominal Sepsis (the COOL trial): study protocol for a randomized controlled trialAndrew W. Kirkpatrick0Federico Coccolini1Luca Ansaloni2Derek J. Roberts3Matti Tolonen4Jessica L. McKee5Ari Leppaniemi6Peter Faris7Christopher J. Doig8Fausto Catena9Timothy Fabian10Craig N. Jenne11Osvaldo Chiara12Paul Kubes13Braden Manns14Yoram KlugerGustavo P. Fraga15Bruno M. Pereira16Jose J. Diaz17Michael Sugrue18Ernest E. Moore19Jianan Ren20Chad G. Ball21Raul Coimbra22Zsolt J. Balogh23Fikri M. Abu-Zidan24Elijah Dixon25Walter Biffl26Anthony MacLean27Ian Ball28John Drover29Paul B. McBeth30Juan G. Posadas-Calleja31Neil G. Parry32Salomone Di Saverio33Carlos A. Ordonez34Jimmy Xiao35Massimo Sartelli36for The Closed Or Open after Laparotomy (COOL) after Source Control for Severe Complicated Intra-Abdominal Sepsis InvestigatorsDepartment of Surgery, University of CalgaryGeneral, Emergency and Trauma Surgery Department, Bufalini HospitalUnit of General and Emergency Surgery, Bufalini Hospital of CesenaDepartment of Surgery, University of CalgaryDepartment of Abdominal Surgery, Abdominal Center, University of Helsinki and Helsinki University Central HospitalRegional Trauma Services, Foothills Medical CentreDepartment of Abdominal Surgery, Abdominal Center, University of Helsinki and Helsinki University Central HospitalResearch Facilitation Analytics (DIMR), University of CalgaryDepartment of Critical Care Medicine, University of CalgaryEmergency Surgery Department, Parma University HospitalSurgery, University of Tennessee Health Sciences Center MemphisDepartment of Critical Care Medicine, University of CalgaryGeneral Surgery and Trauma Team Niguarda Hospital MilanoCalvin, Phoebe and Joan Snyder Institute for Chronic Diseases, University of CalgaryEmergency Surgery Department, Parma University HospitalDivision of Trauma Surgery, University of CampinasDivision of Trauma Surgery, University of CampinasDepartment of Surgery, R Adams Cowley Shock Trauma Center, University of Maryland School on MedicineDonegal Clinical Research Academy, Letterkenny University HospitalTrauma and Critical Care Research, University of ColoradoDepartment of Surgery, Jinling Hospital, Medical School of Nanjing UniversityGeneral, Acute Care, and Hepatobiliary Surgery, and Regional Trauma Services, University of CalgaryRiverside University Health System Medical CenterJohn Hunter Hospital and Hunter New England Health DistrictDepartment of Surgery, College of Medicine and Health Sciences, UAE UniversityDepartment of Surgery, University of CalgaryScripps Memorial Hospital La JollaDepartment of Surgery, University of CalgaryDepartment of Medicine, Western UniversityDepartment of Critical Care Medicine, Queen’s UniversityDepartment of Surgery, University of CalgaryDepartment of Critical Care Medicine, University of CalgaryDepartment of Surgery, Western University, Victoria Hospital, London Health Sciences CentreAddenbrooke’s Hospital, Cambridge University Hospitals NHS Foundation TrustDepartment of Surgery, Fundación Valle del Lili and Universidad Del ValleRegional Trauma Services, Foothills Medical CentreDepartment of Surgery, Macerata HospitalAbstract 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.http://link.springer.com/article/10.1186/s13017-018-0183-4Intra-peritoneal sepsisSeptic shockPeritonitisOpen-abdomenMultiple organ dysfunctionLaparotomy |
| spellingShingle | 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 for The Closed Or Open after Laparotomy (COOL) after Source Control for Severe Complicated Intra-Abdominal Sepsis Investigators 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 Intra-peritoneal sepsis Septic shock Peritonitis Open-abdomen Multiple organ dysfunction Laparotomy |
| title | Closed Or Open after Source Control Laparotomy for Severe Complicated Intra-Abdominal Sepsis (the COOL trial): study protocol for a randomized controlled trial |
| title_full | Closed Or Open after Source Control Laparotomy for Severe Complicated Intra-Abdominal Sepsis (the COOL trial): study protocol for a randomized controlled trial |
| title_fullStr | Closed Or Open after Source Control Laparotomy for Severe Complicated Intra-Abdominal Sepsis (the COOL trial): study protocol for a randomized controlled trial |
| title_full_unstemmed | Closed Or Open after Source Control Laparotomy for Severe Complicated Intra-Abdominal Sepsis (the COOL trial): study protocol for a randomized controlled trial |
| title_short | Closed Or Open after Source Control Laparotomy for Severe Complicated Intra-Abdominal Sepsis (the COOL trial): study protocol for a randomized controlled trial |
| title_sort | closed or open after source control laparotomy for severe complicated intra abdominal sepsis the cool trial study protocol for a randomized controlled trial |
| topic | Intra-peritoneal sepsis Septic shock Peritonitis Open-abdomen Multiple organ dysfunction Laparotomy |
| url | http://link.springer.com/article/10.1186/s13017-018-0183-4 |
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