The unrestricted global effort to complete the COOL trial

Kirkpatrick, Andrew W.; Coccolini, Federico; Tolonen, Matti; Minor, Samuel; Catena, Fausto; Gois, Emanuel; Doig, Christopher J.; Hill, Michael D.; Ansaloni, Luca; Chiarugi, Massimo; Tartaglia, Dario; Ioannidis, Orestis; Sugrue, Michael; Colak, Elif; Hameed, S. Morad; Lampela, Hanna; Agnoletti, Vanni; McKee, Jessica L.; Garraway, Naisan; Sartelli, Massimo; Ball, Chad G.; Parry, Neil G.; Voght, Kelly; Julien, Lisa; Kroeker, Jenna; Roberts, Derek J.; Faris, Peter; Tiruta, Corina; Moore, Ernest E.; Ammons, Lee Anne; Anestiadou, Elissavet; Bendinelli, Cino; Bouliaris, Konstantinos; Carroll, Rosemarry; Ceresoli, Marco; Favi, Francesco; Gurrado, Angela; Rezende-Neto, Joao; Isik, Arda; Cremonini, Camilla; Strambi, Silivia; Koukoulis, Georgios; Testini, Mario; Trpcic, Sandy; Pasculli, Alessandro; Picariello, Erika; Abu-Zidan, Fikri; Adeyeye, Ademola; Augustin, Goran; Alconchel, Felipe; Altinel, Yuksel; Hernandez Amin, Luz Adriana; Aranda-Narváez, José Manuel; Baraket, Oussama; Biffl, Walter L.; Baiocchi, Gian Luca; Bonavina, Luigi; Brisinda, Giuseppe; Cardinali, Luca; Celotti, Andrea; Chaouch, Mohamed; Chiarello, Maria; Costa, Gianluca; de’Angelis, Nicola; De Manzini, Nicolo; Delibegovic, Samir; Di Saverio, Salomone; De Simone, Belinda; Dubuisson, Vincent; Fransvea, Pietro; Garulli, Gianluca; Giordano, Alessio; Gomes, Carlos; Hayati, Firdaus; Huang, Jinjian; Ibrahim, Aini Fahriza; Huei, Tan Jih; Jailani, Ruhi Fadzlyana; Khan, Mansoor; Luna, Alfonso Palmieri; Malbrain, Manu L. N. G.; Marwah, Sanjay; McBeth, Paul; Mihailescu, Andrei; Morello, Alessia; Mulita, Francesk; Murzi, Valentina; Mohammad, Ahmad Tarmizi; Parmar, Simran; Pak, Ajay; Wong, Michael Pak-Kai; Pantalone, Desire; Podda, Mauro; Puccioni, Caterina; Rasa, Kemal; Ren, Jianan; Roscio, Francesco; Gonzalez-Sanchez, Antonio; Sganga, Gabriele; Scheiterle, Maximilian; Slavchev, Mihail; Smirnov, Dmitry; Tosi, Lorenzo; Trivedi, Anand; Vega, Jaime Andres Gonzalez; Waledziak, Maciej; Xenaki, Sofia; Winter, Desmond; Wu, Xiuwen; Zakaria, Andee Dzulkarnean; Zakaria, Zaidi

doi:10.1186/s13017-023-00500-z

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Scientific paper - Original scientific paper

The unrestricted global effort to complete the COOL trial

World Journal of Emergency Surgery, 18 (2023), 1; 33. https://doi.org/10.1186/s13017-023-00500-z

Kirkpatrick, Andrew W.; Coccolini, Federico; Tolonen, Matti; Minor, Samuel; Catena, Fausto; Gois, Emanuel; Doig, Christopher J.; Hill, Michael D.; Ansaloni, Luca; Chiarugi, Massimo; Tartaglia, Dario; Ioannidis, Orestis; Sugrue, Michael; Colak, Elif; Hameed, S. Morad; Lampela, Hanna; Agnoletti, Vanni; McKee, Jessica L.; Garraway, Naisan; Sartelli, Massimo; Ball, Chad G.; Parry, Neil G.; Voght, Kelly; Julien, Lisa; Kroeker, Jenna; Roberts, Derek J.; Faris, Peter; Tiruta, Corina; Moore, Ernest E.; Ammons, Lee Anne; Anestiadou, Elissavet; Bendinelli, Cino; Bouliaris, Konstantinos; Carroll, Rosemarry; Ceresoli, Marco; Favi, Francesco; Gurrado, Angela; Rezende-Neto, Joao; Isik, Arda; Cremonini, Camilla; Strambi, Silivia; Koukoulis, Georgios; Testini, Mario; Trpcic, Sandy; Pasculli, Alessandro; Picariello, Erika; Abu-Zidan, Fikri; Adeyeye, Ademola; Augustin, Goran; Alconchel, Felipe; Altinel, Yuksel; Hernandez Amin, Luz Adriana; Aranda-Narváez, José Manuel; Baraket, Oussama; Biffl, Walter L.; Baiocchi, Gian Luca; Bonavina, Luigi; Brisinda, Giuseppe; Cardinali, Luca; Celotti, Andrea; Chaouch, Mohamed; Chiarello, Maria; Costa, Gianluca; de’Angelis, Nicola; De Manzini, Nicolo; Delibegovic, Samir; Di Saverio, Salomone; De Simone, Belinda; Dubuisson, Vincent; Fransvea, Pietro; Garulli, Gianluca; Giordano, Alessio; Gomes, Carlos; Hayati, Firdaus; Huang, Jinjian; Ibrahim, Aini Fahriza; Huei, Tan Jih; Jailani, Ruhi Fadzlyana; Khan, Mansoor; Luna, Alfonso Palmieri; Malbrain, Manu L. N. G.; Marwah, Sanjay; McBeth, Paul; Mihailescu, Andrei; Morello, Alessia; Mulita, Francesk; Murzi, Valentina; Mohammad, Ahmad Tarmizi; Parmar, Simran; Pak, Ajay; Wong, Michael Pak-Kai; Pantalone, Desire; Podda, Mauro; Puccioni, Caterina; Rasa, Kemal; Ren, Jianan; Roscio, Francesco; Gonzalez-Sanchez, Antonio; Sganga, Gabriele; Scheiterle, Maximilian; Slavchev, Mihail; Smirnov, Dmitry; Tosi, Lorenzo; Trivedi, Anand; Vega, Jaime Andres Gonzalez; Waledziak, Maciej; Xenaki, Sofia; Winter, Desmond; Wu, Xiuwen; Zakaria, Andee Dzulkarnean; Zakaria, Zaidi More authors...

Cite this document

APA 6th Edition

Kirkpatrick, A. W., Coccolini, F., Tolonen, M., Minor, S., Catena, F., Gois, E. ... Zakaria, Z. (2023). The unrestricted global effort to complete the COOL trial. World Journal of Emergency Surgery, 18. (1). doi: 10.1186/s13017-023-00500-z

MLA 8th Edition

Kirkpatrick, Andrew W., et al. "The unrestricted global effort to complete the COOL trial." World Journal of Emergency Surgery, vol. 18, no. 1, 2023. https://doi.org/10.1186/s13017-023-00500-z

Chicago 17th Edition

Kirkpatrick, Andrew W., Federico Coccolini, Matti Tolonen, Samuel Minor, Fausto Catena, Emanuel Gois, Christopher J. Doig, et al. "The unrestricted global effort to complete the COOL trial." World Journal of Emergency Surgery 18, no. 1 (2023). https://doi.org/10.1186/s13017-023-00500-z

Harvard

Kirkpatrick, A. W., et al. (2023) 'The unrestricted global effort to complete the COOL trial', World Journal of Emergency Surgery, 18(1). doi: 10.1186/s13017-023-00500-z

Vancouver

Kirkpatrick AW, Coccolini F, Tolonen M, Minor S, Catena F, Gois E, and sur.. The unrestricted global effort to complete the COOL trial. World Journal of Emergency Surgery [Internet]. 2023 May 11 [cited 2024 May 02];18(1). doi: 10.1186/s13017-023-00500-z

IEEE

A. W. Kirkpatrick, et al., "The unrestricted global effort to complete the COOL trial", World Journal of Emergency Surgery, vol. 18, no. 1, May 2023. [Online]. Available at: https://urn.nsk.hr/urn:nbn:hr:105:105136. [Accessed: 02 May 2024]

Cite this item: https://urn.nsk.hr/urn:nbn:hr:105:105136

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Metadata

Title (english)	The unrestricted global effort to complete the COOL trial
Author	Andrew W. Kirkpatrick
Author	Federico Coccolini
Author	Matti Tolonen
Author	Samuel Minor
Author	Fausto Catena
Author	Emanuel Gois
Author	Christopher J. Doig
Author	Michael D. Hill
Author	Luca Ansaloni
Author	Massimo Chiarugi
Author	Dario Tartaglia
Author	Orestis Ioannidis
Author	Michael Sugrue
Author	Elif Colak
Author	S. Morad Hameed
Author	Hanna Lampela
Author	Vanni Agnoletti
Author	Jessica L. McKee
Author	Naisan Garraway
Author	Massimo Sartelli
Author	Chad G. Ball
Author	Neil G. Parry
Author	Kelly Voght
Author	Lisa Julien
Author	Jenna Kroeker
Author	Derek J. Roberts
Author	Peter Faris
Author	Corina Tiruta
Author	Ernest E. Moore
Author	Lee Anne Ammons
Author	Elissavet Anestiadou
Author	Cino Bendinelli
Author	Konstantinos Bouliaris
Author	Rosemarry Carroll
Author	Marco Ceresoli
Author	Francesco Favi
Author	Angela Gurrado
Author	Joao Rezende-Neto
Author	Arda Isik
Author	Camilla Cremonini
Author	Silivia Strambi
Author	Georgios Koukoulis
Author	Mario Testini
Author	Sandy Trpcic
Author	Alessandro Pasculli
Author	Erika Picariello
Author	Fikri Abu-Zidan
Author	Ademola Adeyeye
Author	Goran Augustin
Author	Felipe Alconchel
Author	Yuksel Altinel
Author	Luz Adriana Hernandez Amin
Author	José Manuel Aranda-Narváez
Author	Oussama Baraket
Author	Walter L. Biffl
Author	Gian Luca Baiocchi
Author	Luigi Bonavina
Author	Giuseppe Brisinda
Author	Luca Cardinali
Author	Andrea Celotti
Author	Mohamed Chaouch
Author	Maria Chiarello
Author	Gianluca Costa
Author	Nicola de’Angelis
Author	Nicolo De Manzini
Author	Samir Delibegovic
Author	Salomone Di Saverio
Author	Belinda De Simone
Author	Vincent Dubuisson
Author	Pietro Fransvea
Author	Gianluca Garulli
Author	Alessio Giordano
Author	Carlos Gomes
Author	Firdaus Hayati
Author	Jinjian Huang
Author	Aini Fahriza Ibrahim
Author	Tan Jih Huei
Author	Ruhi Fadzlyana Jailani
Author	Mansoor Khan
Author	Alfonso Palmieri Luna
Author	Manu L. N. G. Malbrain
Author	Sanjay Marwah
Author	Paul McBeth
Author	Andrei Mihailescu
Author	Alessia Morello
Author	Francesk Mulita
Author	Valentina Murzi
Author	Ahmad Tarmizi Mohammad
Author	Simran Parmar
Author	Ajay Pak
Author	Michael Pak-Kai Wong
Author	Desire Pantalone
Author	Mauro Podda
Author	Caterina Puccioni
Author	Kemal Rasa
Author	Jianan Ren
Author	Francesco Roscio
Author	Antonio Gonzalez-Sanchez
Author	Gabriele Sganga
Author	Maximilian Scheiterle
Author	Mihail Slavchev
Author	Dmitry Smirnov
Author	Lorenzo Tosi
Author	Anand Trivedi
Author	Jaime Andres Gonzalez Vega
Author	Maciej Waledziak
Author	Sofia Xenaki
Author	Desmond Winter
Author	Xiuwen Wu
Author	Andee Dzulkarnean Zakaria
Author	Zaidi Zakaria
Author's institution	University of Zagreb School of Medicine (Department of Surgery)
Scientific / art field, discipline and subdiscipline	BIOMEDICINE AND HEALTHCARE Clinical Medical Sciences Surgery
Abstract (english)	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. A further therapeutic option may be open abdomen (OA) management with negative peritoneal pressure therapy (NPPT) to remove inflammatory ascites and attenuate the systemic damage from SCIAS, although there are definite risks of leaving the abdomen open whenever it might possibly be closed. This potential therapeutic paradigm is the rationale being assessed in the Closed Or Open after Laparotomy (COOL trial) ( https://clinicaltrials.gov/ct2/show/NCT03163095 ). Initially, the COOL trial received Industry sponsorship; however, this funding mandated the use of a specific trademarked and expensive NPPT device in half of the patients allocated to the intervention (open) arm. In August 2022, the 3 M/Acelity Corporation without consultation but within the terms of the contract canceled the financial support of the trial. Although creating financial difficulty, there is now no restriction on specific NPPT devices and removing a cost-prohibitive intervention creates an opportunity to expand the COOL trial to a truly global basis. This document describes the evolution of the COOL trial, with a focus on future opportunities for global growth of the study. Methods: The COOL trial is the largest prospective randomized controlled trial examining the random allocation of SCIAS patients intra-operatively to either formal closure of the fascia or the use of the OA with an application of an NPPT dressing. Patients are eligible if they have free uncontained intraperitoneal contamination and physiologic derangements exemplified by septic shock OR severely adverse predicted clinical outcomes. The primary outcome is intended to definitively inform global practice by conclusively evaluating 90-day survival. Initial recruitment has been lower than hoped but satisfactory, and the COOL steering committee and trial investigators intend with increased global support to continue enrollment until recruitment ensures a definitive answer. Discussion: OA is mandated in many cases of SCIAS such as the risk of abdominal compartment syndrome associated with closure, or a planned second look as for example part of "damage control"; however, improved source control (locally and systemically) is the most uncertain indication for an OA. The COOL trial seeks to expand potential sites and proceed with the evaluation of NPPT agnostic to device, to properly examine the hypothesis that this treatment attenuates systemic damage and improves survival. This approach will not affect internal validity and should improve the external validity of any observed results of the intervention.
Keywords (english)
Language	english
Publication type	Scientific paper - Original scientific paper
Publication status	Published
Peer review	Peer review
Publication version	Published version
Journal title	World Journal of Emergency Surgery
Numbering	vol. 18, no. 1, 33
e-ISSN	1749-7922
DOI	https://doi.org/10.1186/s13017-023-00500-z
URN:NBN	urn:nbn:hr:105:105136
Publication	2023-05-11
Document URL	https://wjes.biomedcentral.com/articles/10.1186/s13017-023-00500-z
Type of resource	Text
Access conditions	Open access
Terms of use
Created on	2023-11-02 09:38:51