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Closed or Open Abdomen for the Management of Abdominal Sepsis

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ClinicalTrials.gov Identifier: NCT03163095

Recruitment Status : Recruiting

First Posted : May 22, 2017

Last Update Posted : February 3, 2023

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View this study on the modernized ClinicalTrials.gov

Sponsor:

Collaborator:

Alberta Health services

Information provided by (Responsible Party):

Andrew W Kirkpatrick, University of Calgary

No Study Results Posted on ClinicalTrials.gov for this Study

About Study Results Reporting on ClinicalTrials.gov

Recruitment Status :	Recruiting
Estimated Primary Completion Date :	July 2025
Estimated Study Completion Date :	December 2025

Publications of Results:

Xiao Z, Wilson C, Robertson HL, Roberts DJ, Ball CG, Jenne CN, Kirkpatrick AW. Inflammatory mediators in intra-abdominal sepsis or injury - a scoping review. Crit Care. 2015 Oct 27;19:373. doi: 10.1186/s13054-015-1093-4.

Kirkpatrick AW, Roberts DJ, Faris PD, Ball CG, Kubes P, Tiruta C, Xiao Z, Holodinsky JK, McBeth PB, Doig CJ, Jenne CN. Active Negative Pressure Peritoneal Therapy After Abbreviated Laparotomy: The Intraperitoneal Vacuum Randomized Controlled Trial. Ann Surg. 2015 Jul;262(1):38-46. doi: 10.1097/SLA.0000000000001095.

Kubiak BD, Albert SP, Gatto LA, Snyder KP, Maier KG, Vieau CJ, Roy S, Nieman GF. Peritoneal negative pressure therapy prevents multiple organ injury in a chronic porcine sepsis and ischemia/reperfusion model. Shock. 2010 Nov;34(5):525-34. doi: 10.1097/SHK.0b013e3181e14cd2.

Opal SM, Dellinger RP, Vincent JL, Masur H, Angus DC. The next generation of sepsis clinical trial designs: what is next after the demise of recombinant human activated protein C?*. Crit Care Med. 2014 Jul;42(7):1714-21. doi: 10.1097/CCM.0000000000000325.

Kirkpatrick AW, Roberts DJ, De Waele J, Jaeschke R, Malbrain ML, De Keulenaer B, Duchesne J, Bjorck M, Leppaniemi A, Ejike JC, Sugrue M, Cheatham M, Ivatury R, Ball CG, Reintam Blaser A, Regli A, Balogh ZJ, D'Amours S, Debergh D, Kaplan M, Kimball E, Olvera C; Pediatric Guidelines Sub-Committee for the World Society of the Abdominal Compartment Syndrome. Intra-abdominal hypertension and the abdominal compartment syndrome: updated consensus definitions and clinical practice guidelines from the World Society of the Abdominal Compartment Syndrome. Intensive Care Med. 2013 Jul;39(7):1190-206. doi: 10.1007/s00134-013-2906-z. Epub 2013 May 15.

Reintam A, Parm P, Kitus R, Kern H, Starkopf J. Primary and secondary intra-abdominal hypertension--different impact on ICU outcome. Intensive Care Med. 2008 Sep;34(9):1624-31. doi: 10.1007/s00134-008-1134-4. Epub 2008 May 1.

Regueira T, Bruhn A, Hasbun P, Aguirre M, Romero C, Llanos O, Castro R, Bugedo G, Hernandez G. Intra-abdominal hypertension: incidence and association with organ dysfunction during early septic shock. J Crit Care. 2008 Dec;23(4):461-7. doi: 10.1016/j.jcrc.2007.12.013. Epub 2008 Apr 18.

Malbrain ML, Chiumello D, Pelosi P, Wilmer A, Brienza N, Malcangi V, Bihari D, Innes R, Cohen J, Singer P, Japiassu A, Kurtop E, De Keulenaer BL, Daelemans R, Del Turco M, Cosimini P, Ranieri M, Jacquet L, Laterre PF, Gattinoni L. Prevalence of intra-abdominal hypertension in critically ill patients: a multicentre epidemiological study. Intensive Care Med. 2004 May;30(5):822-9. doi: 10.1007/s00134-004-2169-9. Epub 2004 Feb 3.

De Waele JJ. Abdominal Sepsis. Curr Infect Dis Rep. 2016 Aug;18(8):23. doi: 10.1007/s11908-016-0531-z.

Leppaniemi A, Kimball EJ, De Laet I, Malbrain ML, Balogh ZJ, De Waele JJ. Management of abdominal sepsis--a paradigm shift? Anaesthesiol Intensive Ther. 2015;47(4):400-8. doi: 10.5603/AIT.a2015.0026. Epub 2015 May 14.

Tellor B, Skrupky LP, Symons W, High E, Micek ST, Mazuski JE. Inadequate Source Control and Inappropriate Antibiotics are Key Determinants of Mortality in Patients with Intra-Abdominal Sepsis and Associated Bacteremia. Surg Infect (Larchmt). 2015 Dec;16(6):785-93. doi: 10.1089/sur.2014.166. Epub 2015 Aug 10.

Tolonen M, Sallinen V, Mentula P, Leppaniemi A. Preoperative prognostic factors for severe diffuse secondary peritonitis: a retrospective study. Langenbecks Arch Surg. 2016 Aug;401(5):611-7. doi: 10.1007/s00423-016-1454-8. Epub 2016 May 30.

Sartelli M, Viale P, Catena F, Ansaloni L, Moore E, Malangoni M, Moore FA, Velmahos G, Coimbra R, Ivatury R, Peitzman A, Koike K, Leppaniemi A, Biffl W, Burlew CC, Balogh ZJ, Boffard K, Bendinelli C, Gupta S, Kluger Y, Agresta F, Di Saverio S, Wani I, Escalona A, Ordonez C, Fraga GP, Junior GA, Bala M, Cui Y, Marwah S, Sakakushev B, Kong V, Naidoo N, Ahmed A, Abbas A, Guercioni G, Vettoretto N, Diaz-Nieto R, Gerych I, Trana C, Faro MP, Yuan KC, Kok KY, Mefire AC, Lee JG, Hong SK, Ghnnam W, Siribumrungwong B, Sato N, Murata K, Irahara T, Coccolini F, Segovia Lohse HA, Verni A, Shoko T. 2013 WSES guidelines for management of intra-abdominal infections. World J Emerg Surg. 2013 Jan 8;8(1):3. doi: 10.1186/1749-7922-8-3.

Sartelli M, Abu-Zidan FM, Catena F, Griffiths EA, Di Saverio S, Coimbra R, Ordonez CA, Leppaniemi A, Fraga GP, Coccolini F, Agresta F, Abbas A, Abdel Kader S, Agboola J, Amhed A, Ajibade A, Akkucuk S, Alharthi B, Anyfantakis D, Augustin G, Baiocchi G, Bala M, Baraket O, Bayrak S, Bellanova G, Beltran MA, Bini R, Boal M, Borodach AV, Bouliaris K, Branger F, Brunelli D, Catani M, Che Jusoh A, Chichom-Mefire A, Cocorullo G, Colak E, Costa D, Costa S, Cui Y, Curca GL, Curry T, Das K, Delibegovic S, Demetrashvili Z, Di Carlo I, Drozdova N, El Zalabany T, Enani MA, Faro M, Gachabayov M, Gimenez Maurel T, Gkiokas G, Gomes CA, Gonsaga RA, Guercioni G, Guner A, Gupta S, Gutierrez S, Hutan M, Ioannidis O, Isik A, Izawa Y, Jain SA, Jokubauskas M, Karamarkovic A, Kauhanen S, Kaushik R, Kenig J, Khokha V, Kim JI, Kong V, Koshy R, Krasniqi A, Kshirsagar A, Kuliesius Z, Lasithiotakis K, Leao P, Lee JG, Leon M, Lizarazu Perez A, Lohsiriwat V, Lopez-Tomassetti Fernandez E, Lostoridis E, Mn R, Major P, Marinis A, Marrelli D, Martinez-Perez A, Marwah S, McFarlane M, Melo RB, Mesina C, Michalopoulos N, Moldovanu R, Mouaqit O, Munyika A, Negoi I, Nikolopoulos I, Nita GE, Olaoye I, Omari A, Ossa PR, Ozkan Z, Padmakumar R, Pata F, Pereira Junior GA, Pereira J, Pintar T, Pouggouras K, Prabhu V, Rausei S, Rems M, Rios-Cruz D, Sakakushev B, Sanchez de Molina ML, Seretis C, Shelat V, Simoes RL, Sinibaldi G, Skrovina M, Smirnov D, Spyropoulos C, Tepp J, Tezcaner T, Tolonen M, Torba M, Ulrych J, Uzunoglu MY, van Dellen D, van Ramshorst GH, Vasquez G, Venara A, Vereczkei A, Vettoretto N, Vlad N, Yadav SK, Yilmaz TU, Yuan KC, Zachariah SK, Zida M, Zilinskas J, Ansaloni L. Global validation of the WSES Sepsis Severity Score for patients with complicated intra-abdominal infections: a prospective multicentre study (WISS Study). World J Emerg Surg. 2015 Dec 16;10:61. doi: 10.1186/s13017-015-0055-0. eCollection 2015.

Sartelli M, Abu-Zidan FM, Ansaloni L, Bala M, Beltran MA, Biffl WL, Catena F, Chiara O, Coccolini F, Coimbra R, Demetrashvili Z, Demetriades D, Diaz JJ, Di Saverio S, Fraga GP, Ghnnam W, Griffiths EA, Gupta S, Hecker A, Karamarkovic A, Kong VY, Kafka-Ritsch R, Kluger Y, Latifi R, Leppaniemi A, Lee JG, McFarlane M, Marwah S, Moore FA, Ordonez CA, Pereira GA, Plaudis H, Shelat VG, Ulrych J, Zachariah SK, Zielinski MD, Garcia MP, Moore EE. The role of the open abdomen procedure in managing severe abdominal sepsis: WSES position paper. World J Emerg Surg. 2015 Aug 12;10:35. doi: 10.1186/s13017-015-0032-7. eCollection 2015.

Dellinger RP, Levy MM, Carlet JM, Bion J, Parker MM, Jaeschke R, Reinhart K, Angus DC, Brun-Buisson C, Beale R, Calandra T, Dhainaut JF, Gerlach H, Harvey M, Marini JJ, Marshall J, Ranieri M, Ramsay G, Sevransky J, Thompson BT, Townsend S, Vender JS, Zimmerman JL, Vincent JL; International Surviving Sepsis Campaign Guidelines Committee; American Association of Critical-Care Nurses; American College of Chest Physicians; American College of Emergency Physicians; Canadian Critical Care Society; European Society of Clinical Microbiology and Infectious Diseases; European Society of Intensive Care Medicine; European Respiratory Society; International Sepsis Forum; Japanese Association for Acute Medicine; Japanese Society of Intensive Care Medicine; Society of Critical Care Medicine; Society of Hospital Medicine; Surgical Infection Society; World Federation of Societies of Intensive and Critical Care Medicine. Surviving Sepsis Campaign: international guidelines for management of severe sepsis and septic shock: 2008. Crit Care Med. 2008 Jan;36(1):296-327. doi: 10.1097/01.CCM.0000298158.12101.41. Erratum In: Crit Care Med. 2008 Apr;36(4):1394-6.

Dellinger RP, Levy MM, Carlet JM, Bion J, Parker MM, Jaeschke R, Reinhart K, Angus DC, Brun-Buisson C, Beale R, Calandra T, Dhainaut JF, Gerlach H, Harvey M, Marini JJ, Marshall J, Ranieri M, Ramsay G, Sevransky J, Thompson BT, Townsend S, Vender JS, Zimmerman JL, Vincent JL. Surviving Sepsis Campaign: international guidelines for management of severe sepsis and septic shock: 2008. Intensive Care Med. 2008 Jan;34(1):17-60. doi: 10.1007/s00134-007-0934-2. Epub 2007 Dec 4. Erratum In: Intensive Care Med. 2008 Apr;34(4):783-5.

Slade E, Tamber PS, Vincent JL. The Surviving Sepsis Campaign: raising awareness to reduce mortality. Crit Care. 2003 Feb;7(1):1-2. doi: 10.1186/cc1876. Epub 2003 Jan 8.

Angus DC, Linde-Zwirble WT, Lidicker J, Clermont G, Carcillo J, Pinsky MR. Epidemiology of severe sepsis in the United States: analysis of incidence, outcome, and associated costs of care. Crit Care Med. 2001 Jul;29(7):1303-10. doi: 10.1097/00003246-200107000-00002.

Other Publications:

Kirkpatrick AW, Sugrue M, McKee JL, Pereira BM, Roberts DJ, De Waele JJ, Leppaniemi A, Ejike JC, Reintam Blaser A, D'Amours S, De Keulenaer B, Malbrain MLNG. Update from the Abdominal Compartment Society (WSACS) on intra-abdominal hypertension and abdominal compartment syndrome: past, present, and future beyond Banff 2017. Anaesthesiol Intensive Ther. 2017;49(2):83-87. doi: 10.5603/AIT.a2017.0019. Epub 2017 May 14. No abstract available.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Ng-Kamstra JS, Rennert-May E, McKee J, Lundgren S, Manns B, Kirkpatrick AW. Protocol for a parallel economic evaluation of a trial comparing two surgical strategies in severe complicated intra-abdominal sepsis: the COOL-cost study. World J Emerg Surg. 2020 Feb 21;15(1):15. doi: 10.1186/s13017-020-00294-4.

Doig CJ, Page SA, McKee JL, Moore EE, Abu-Zidan FM, Carroll R, Marshall JC, Faris PD, Tolonen M, Catena F, Cocolini F, Sartelli M, Ansaloni L, Minor SF, Peirera BM, Diaz JJ, Kirkpatrick AW; Closed Or Open after Laparotomy (COOL) after Source Control for Severe Complicated Intra-Abdominal Sepsis Investigators. Ethical considerations in conducting surgical research in severe complicated intra-abdominal sepsis. World J Emerg Surg. 2019 Aug 5;14:39. doi: 10.1186/s13017-019-0259-9. eCollection 2019. Erratum In: World J Emerg Surg. 2019 Oct 17;14:47.

Kirkpatrick AW, Coccolini F, Ansaloni L, Roberts DJ, Tolonen M, McKee JL, Leppaniemi A, Faris P, Doig CJ, Catena F, Fabian T, Jenne CN, Chiara O, Kubes P, Manns B, Kluger Y, Fraga GP, Pereira BM, Diaz JJ, Sugrue M, Moore EE, Ren J, Ball CG, Coimbra R, Balogh ZJ, Abu-Zidan FM, Dixon E, Biffl W, MacLean A, Ball I, Drover J, McBeth PB, Posadas-Calleja JG, Parry NG, Di Saverio S, Ordonez CA, Xiao J, Sartelli M; 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 J Emerg Surg. 2018 Jun 22;13:26. doi: 10.1186/s13017-018-0183-4. eCollection 2018.

Tolonen M, Coccolini F, Ansaloni L, Sartelli M, Roberts DJ, McKee JL, Leppaniemi A, Doig CJ, Catena F, Fabian T, Jenne CN, Chiara O, Kubes P, Kluger Y, Fraga GP, Pereira BM, Diaz JJ, Sugrue M, Moore EE, Ren J, Ball CG, Coimbra R, Dixon E, Biffl W, MacLean A, McBeth PB, Posadas-Calleja JG, Di Saverio S, Xiao J, Kirkpatrick AW; From the Closed Or Open after Laparotomy (COOL) for Source Control in Severe Complicated Intra-Abdominal Sepsis Investigators. Getting the invite list right: a discussion of sepsis severity scoring systems in severe complicated intra-abdominal sepsis and randomized trial inclusion criteria. World J Emerg Surg. 2018 Apr 6;13:17. doi: 10.1186/s13017-018-0177-2. eCollection 2018.