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World Journal of Emergency Surgery
Published in: World Journal of Emergency Surgery 1/2018

Open Access 01-12-2018 | Study protocol

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

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, for The Closed Or Open after Laparotomy (COOL) after Source Control for Severe Complicated Intra-Abdominal Sepsis Investigators

Published in: World Journal of Emergency Surgery | Issue 1/2018

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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

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Metadata
Title
Closed Or Open after Source Control Laparotomy for Severe Complicated Intra-Abdominal Sepsis (the COOL trial): study protocol for a randomized controlled trial
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
for The Closed Or Open after Laparotomy (COOL) after Source Control for Severe Complicated Intra-Abdominal Sepsis Investigators
Publication date
01-12-2018
Publisher
BioMed Central
Published in
World Journal of Emergency Surgery / Issue 1/2018
Electronic ISSN: 1749-7922
DOI
https://doi.org/10.1186/s13017-018-0183-4

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