The unrestricted global effort to complete the COOL trial

Simple item page
dc.contributor.authorKirkpatrick, Andrew W.
dc.contributor.authorCoccolini, Federico
dc.contributor.authorTolonen, Matti
dc.contributor.authorMinor, Samuel
dc.contributor.authorCatena, Fausto
dc.contributor.authorGois, Emanuel
dc.contributor.authorDoig, Christopher J.
dc.contributor.authorHill, Michael D.
dc.contributor.authorAnsaloni, Luca
dc.contributor.authorChiarugi, Massimo
dc.contributor.authorTartaglia, Dario
dc.contributor.authorIoannidis, Orestis
dc.contributor.authorSugrue, Michael
dc.contributor.authorColak, Elif
dc.contributor.authorHameed, S. M.
dc.contributor.authorLampela, Hanna
dc.contributor.authorAgnoletti, Vanni
dc.contributor.authorMcKee, Jessica L.
dc.contributor.authorGarraway, Naisan
dc.contributor.authorSartelli, Massimo
dc.contributor.authorBall, Chad G.
dc.contributor.authorParry, Neil G.
dc.contributor.authorVoght, Kelly
dc.contributor.authorJulien, Lisa
dc.contributor.authorKroeker, Jenna
dc.contributor.authorRoberts, Derek J.
dc.contributor.authorFaris, Peter
dc.contributor.authorTiruta, Corina
dc.contributor.authorMoore, Ernest E.
dc.contributor.authorAmmons, Lee A.
dc.contributor.authorAnestiadou, Elissavet
dc.contributor.authorBendinelli, Cino
dc.contributor.authorBouliaris, Konstantinos
dc.contributor.authorCarroll, Rosemarry
dc.contributor.authorCeresoli, Marco
dc.contributor.authorFavi, Francesco
dc.contributor.authorGurrado, Angela
dc.contributor.authorRezende-Neto, Joao
dc.contributor.authorIsik, Arda
dc.contributor.authorCremonini, Camilla
dc.contributor.authorStrambi, Silivia
dc.contributor.authorKoukoulis, Georgios
dc.contributor.authorTestini, Mario
dc.contributor.authorTrpcic, Sandy
dc.contributor.authorPasculli, Alessandro
dc.contributor.authorPicariello, Erika
dc.contributor.authorAbu-Zidan, Fikri
dc.contributor.authorAdeyeye, Ademola
dc.contributor.authorAugustin, Goran
dc.contributor.authorAlconchel, Felipe
dc.contributor.authorAltinel, Yuksel
dc.contributor.authorHernandez Amin, Luz A.
dc.contributor.authorAranda-Narváez, José M.
dc.contributor.authorBaraket, Oussama
dc.contributor.authorBiffl, Walter L.
dc.contributor.authorBaiocchi, Gian L.
dc.contributor.authorBonavina, Luigi
dc.contributor.authorBrisinda, Giuseppe
dc.contributor.authorCardinali, Luca
dc.contributor.authorCelotti, Andrea
dc.contributor.authorChaouch, Mohamed
dc.contributor.authorChiarello, Maria
dc.contributor.authorCosta, Gianluca
dc.contributor.authorde’Angelis, Nicola
dc.contributor.authorDe Manzini, Nicolo
dc.contributor.authorDelibegovic, Samir
dc.contributor.authorDi Saverio, Salomone
dc.contributor.authorDe Simone, Belinda
dc.contributor.authorDubuisson, Vincent
dc.contributor.authorFransvea, Pietro
dc.contributor.authorGarulli, Gianluca
dc.contributor.authorGiordano, Alessio
dc.contributor.authorGomes, Carlos
dc.contributor.authorHayati, Firdaus
dc.contributor.authorHuang, Jinjian
dc.contributor.authorIbrahim, Aini F.
dc.contributor.authorHuei, Tan J.
dc.contributor.authorJailani, Ruhi F.
dc.contributor.authorKhan, Mansoor
dc.contributor.authorLuna, Alfonso P.
dc.contributor.authorMalbrain, Manu L. N. G.
dc.contributor.authorMarwah, Sanjay
dc.contributor.authorMcBeth, Paul
dc.contributor.authorMihailescu, Andrei
dc.contributor.authorMorello, Alessia
dc.contributor.authorMulita, Francesk
dc.contributor.authorMurzi, Valentina
dc.contributor.authorMohammad, Ahmad T.
dc.contributor.authorParmar, Simran
dc.contributor.authorPak, Ajay
dc.contributor.authorWong, Michael P.
dc.contributor.authorPantalone, Desire
dc.contributor.authorPodda, Mauro
dc.contributor.authorPuccioni, Caterina
dc.contributor.authorRasa, Kemal
dc.contributor.authorRen, Jianan
dc.contributor.authorRoscio, Francesco
dc.contributor.authorGonzalez-Sanchez, Antonio
dc.contributor.authorSganga, Gabriele
dc.contributor.authorScheiterle, Maximilian
dc.contributor.authorSlavchev, Mihail
dc.contributor.authorSmirnov, Dmitry
dc.contributor.authorTosi, Lorenzo
dc.contributor.authorTrivedi, Anand
dc.contributor.authorVega, Jaime A. G.
dc.contributor.authorWaledziak, Maciej
dc.contributor.authorXenaki, Sofia
dc.contributor.authorWinter, Desmond
dc.contributor.authorWu, Xiuwen
dc.contributor.authorZakaria, Andee D.
dc.contributor.authorZakaria, Zaidi
dc.date.accessioned2023-05-14T00:04:24Z
dc.date.available2023-05-14T00:04:24Z
dc.date.issued2023-05-11
dc.date.updated2023-05-14T00:04:24Z
dc.description.abstractAbstract 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. Trial registration: National Institutes of Health ( https://clinicaltrials.gov/ct2/show/NCT03163095 ).
dc.identifier.citationWorld Journal of Emergency Surgery. 2023 May 11;18(1):33
dc.identifier.urihttps://doi.org/10.1186/s13017-023-00500-z
dc.identifier.urihttp://hdl.handle.net/1880/116531
dc.identifier.urihttps://dx.doi.org/10.11575/PRISM/dspace/41374
dc.language.rfc3066en
dc.rights.holderThe Author(s)
dc.titleThe unrestricted global effort to complete the COOL trial
dc.typeJournal Article
Files
Original bundle
Now showing 1 - 1 of 1
Thumbnail Image
Name:
13017_2023_Article_500.pdf
Size:
1.82 MB
Format:
Adobe Portable Document Format
Download
License bundle
Now showing 1 - 1 of 1
No Thumbnail Available
Name:
license.txt
Size:
2.25 KB
Format:
Item-specific license agreed upon to submission
Description:
Download
Collections
Open Access Publications