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

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 m...

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Autores principales: Kirkpatrick, Andrew W., Coccolini, Federico, Ansaloni, Luca, Roberts, Derek J., Tolonen, Matti, McKee, Jessica L., Leppaniemi, Ari, Faris, Peter, Doig, Christopher J., Catena, Fausto, Fabian, Timothy, Jenne, Craig N., Chiara, Osvaldo, Kubes, Paul, Manns, Braden, Kluger, Yoram, Fraga, Gustavo P., Pereira, Bruno M., Diaz, Jose J., Sugrue, Michael, Moore, Ernest E., Ren, Jianan, Ball, Chad G., Coimbra, Raul, Balogh, Zsolt J., Abu-Zidan, Fikri M., Dixon, Elijah, Biffl, Walter, MacLean, Anthony, Ball, Ian, Drover, John, McBeth, Paul B., Posadas-Calleja, Juan G., Parry, Neil G., Di Saverio, Salomone, Ordonez, Carlos A., Xiao, Jimmy, Sartelli, Massimo
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6015449/
https://www.ncbi.nlm.nih.gov/pubmed/29977328
http://dx.doi.org/10.1186/s13017-018-0183-4
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author Kirkpatrick, Andrew W.
Coccolini, Federico
Ansaloni, Luca
Roberts, Derek J.
Tolonen, Matti
McKee, Jessica L.
Leppaniemi, Ari
Faris, Peter
Doig, Christopher J.
Catena, Fausto
Fabian, Timothy
Jenne, Craig N.
Chiara, Osvaldo
Kubes, Paul
Manns, Braden
Kluger, Yoram
Fraga, Gustavo P.
Pereira, Bruno M.
Diaz, Jose J.
Sugrue, Michael
Moore, Ernest E.
Ren, Jianan
Ball, Chad G.
Coimbra, Raul
Balogh, Zsolt J.
Abu-Zidan, Fikri M.
Dixon, Elijah
Biffl, Walter
MacLean, Anthony
Ball, Ian
Drover, John
McBeth, Paul B.
Posadas-Calleja, Juan G.
Parry, Neil G.
Di Saverio, Salomone
Ordonez, Carlos A.
Xiao, Jimmy
Sartelli, Massimo
author_facet Kirkpatrick, Andrew W.
Coccolini, Federico
Ansaloni, Luca
Roberts, Derek J.
Tolonen, Matti
McKee, Jessica L.
Leppaniemi, Ari
Faris, Peter
Doig, Christopher J.
Catena, Fausto
Fabian, Timothy
Jenne, Craig N.
Chiara, Osvaldo
Kubes, Paul
Manns, Braden
Kluger, Yoram
Fraga, Gustavo P.
Pereira, Bruno M.
Diaz, Jose J.
Sugrue, Michael
Moore, Ernest E.
Ren, Jianan
Ball, Chad G.
Coimbra, Raul
Balogh, Zsolt J.
Abu-Zidan, Fikri M.
Dixon, Elijah
Biffl, Walter
MacLean, Anthony
Ball, Ian
Drover, John
McBeth, Paul B.
Posadas-Calleja, Juan G.
Parry, Neil G.
Di Saverio, Salomone
Ordonez, Carlos A.
Xiao, Jimmy
Sartelli, Massimo
author_sort Kirkpatrick, Andrew W.
collection PubMed
description 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.
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spelling pubmed-60154492018-07-05 Closed Or Open after Source Control Laparotomy for Severe Complicated Intra-Abdominal Sepsis (the COOL trial): study protocol for a randomized controlled trial Kirkpatrick, Andrew W. Coccolini, Federico Ansaloni, Luca Roberts, Derek J. Tolonen, Matti McKee, Jessica L. Leppaniemi, Ari Faris, Peter Doig, Christopher J. Catena, Fausto Fabian, Timothy Jenne, Craig N. Chiara, Osvaldo Kubes, Paul Manns, Braden Kluger, Yoram Fraga, Gustavo P. Pereira, Bruno M. Diaz, Jose J. Sugrue, Michael Moore, Ernest E. Ren, Jianan Ball, Chad G. Coimbra, Raul Balogh, Zsolt J. Abu-Zidan, Fikri M. Dixon, Elijah Biffl, Walter MacLean, Anthony Ball, Ian Drover, John McBeth, Paul B. Posadas-Calleja, Juan G. Parry, Neil G. Di Saverio, Salomone Ordonez, Carlos A. Xiao, Jimmy Sartelli, Massimo World J Emerg Surg Study Protocol 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. BioMed Central 2018-06-22 /pmc/articles/PMC6015449/ /pubmed/29977328 http://dx.doi.org/10.1186/s13017-018-0183-4 Text en © The Author(s). 2018 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Study Protocol
Kirkpatrick, Andrew W.
Coccolini, Federico
Ansaloni, Luca
Roberts, Derek J.
Tolonen, Matti
McKee, Jessica L.
Leppaniemi, Ari
Faris, Peter
Doig, Christopher J.
Catena, Fausto
Fabian, Timothy
Jenne, Craig N.
Chiara, Osvaldo
Kubes, Paul
Manns, Braden
Kluger, Yoram
Fraga, Gustavo P.
Pereira, Bruno M.
Diaz, Jose J.
Sugrue, Michael
Moore, Ernest E.
Ren, Jianan
Ball, Chad G.
Coimbra, Raul
Balogh, Zsolt J.
Abu-Zidan, Fikri M.
Dixon, Elijah
Biffl, Walter
MacLean, Anthony
Ball, Ian
Drover, John
McBeth, Paul B.
Posadas-Calleja, Juan G.
Parry, Neil G.
Di Saverio, Salomone
Ordonez, Carlos A.
Xiao, Jimmy
Sartelli, Massimo
Closed Or Open after Source Control Laparotomy for Severe Complicated Intra-Abdominal Sepsis (the COOL trial): study protocol for a randomized controlled trial
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 Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6015449/
https://www.ncbi.nlm.nih.gov/pubmed/29977328
http://dx.doi.org/10.1186/s13017-018-0183-4
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