Closed or Open Abdomen for the Management of Abdominal Sepsis

NCT03163095 | Unknown

• 1 other identifier: REB16-1588-the COOL study
• Study Type: interventional
• Target: 550
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective randomized clinical study. The study will comprise the randomized decision to either A) primarily close the fascia after laparotomy for intra-abdominal infection (CLOSED); or B) leave the fascia open after laparotomy and apply a temporary abdominal closure (TAC) device (OPEN) with a vacuum drain. Although debatable, both procedures (CLOSED or OPEN abdomen) are acceptable based on current suggested standard of care. Thus, high quality data to direct clinical decision making in this highly lethal condition is urgently required.

Conditions

Abdominal Sepsis; Abdominal Infection

Keywords

sepsis; abdominal infection; open abdomen management; Negative pressure peritoneal therapy

Outcome Measures

Primary Outcomes (1)

• The numbers of participants who are survival in hospital stay

  The rate of survival of participants in both arms

  90 days after participants enrolled in the study

Secondary Outcomes (2)

• The days of intensive care unit stay

  30 days after participants enrolled in the study

• The pg/ml of blood Interleukin-6

  72 hours after participants enrolled in the study

Study Arms (2)

Open Abdomen Management with ANPPT dressing

ACTIVE COMPARATOR

The abdominal fascia will not be closed, but a temporally abdomenal closure (TAC) dressing (such as AbThera dressing) will be placed to protect the viscera with active Negative Pressure Peritoneal drain. Formal abdominal closure or dressing change at 24-72 hours from placement should be performed.

Device: Open Abdomen Management with ANPPT dressing

Closed Abdomen Management

SHAM COMPARATOR

Primary closure of the abdominal fascia with placement of an intra-peritoneal drain (such as a Jackson-Pratt drain). Any decision to perform a re-laparotomy will be at the discretion of the treating surgical team.

Other: Closed Abdomen Management

Interventions

Open Abdomen Management with ANPPT dressing DEVICE

The abdominal fascia will not be closed, but a temporally abdominal closure (TAC) dressing, such as AbThera dressing, will be placed to protect the viscera with active Negative Pressure Peritoneal Therapy. The time that the TAC dressing will be changed will be left to the discretion of the attending surgeon, but practice guidelines mandate either formal abdominal closure or dressing change at 24-72 hours from placement. Blood samples and peritoneal fluid will be drawn up to 72 hours after enrollment.

Open Abdomen Management with ANPPT dressing

Closed Abdomen Management OTHER

Primary closure of the abdominal fascia with placement of an intra-peritoneal drain (such as a Jackson-Pratt drain). This strategy will allow drainage of intra-peritoneal fluid for both clinical reasons and to facilitate intra-peritoneal fluid testing. Closure or not of the skin will be left to the attending surgeons discretion. Any decision to perform a relaparotomy (Relaparotomy on Demand) will be at the discretion of the treating critical care teams, and in no way mandated by this recruitment. Blood samples and peritoneal fluid (if available) will be drawn up to 72 hours after enrollment.

Closed Abdomen Management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Presence of purulent, feculent, or enteric spillage over at least 2 intra-peritoneal quadrants intra-operatively;
• Septic shock, or
• Predisposition-Infection-Response-Organ Dysfunction Score \> 3, or
• World-Society-of-Emergency-Surgery-Sepsis-Severity-Score \> 8

You may not qualify if:

• Pregnant;
• Confirmed or strongly suspected severe IAH (IAP\>20 mmHg);
• No intentional of providing ongoing care;
• pancreatitis as the source of peritonitis;
• uncontrolled bleeding

Sponsors & Collaborators

• University of Calgary: lead
• Alberta Health services: collaborator

Study Sites (1)

Foothills Medical Centre

Calgary, Alberta, T2N 2T9, Canada

RECRUITING

Related Publications (25)

• 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.

  PMID: 28502071 BACKGROUND

• 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.

  PMID: 26502877 RESULT

• 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.

  PMID: 25536308 RESULT

• 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.

  PMID: 20823698 RESULT

• 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.

  PMID: 24717456 RESULT

• 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.

  PMID: 23673399 RESULT

• 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.

  PMID: 18446319 RESULT

• 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.

  PMID: 19056007 RESULT

• 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.

  PMID: 14758472 RESULT

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

  PMID: 27363829 RESULT

• 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.

  PMID: 25973662 RESULT

• 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.

  PMID: 26258265 RESULT

• 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.

  PMID: 27241334 RESULT

• 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.

  PMID: 23294512 RESULT

• 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.

  PMID: 26677396 RESULT

• 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.

  PMID: 26269709 RESULT

• 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.

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• 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.

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• Kirkpatrick AW, Coccolini F, Tolonen M, Minor S, Catena F, Gois E Jr, Doig CJ, Hill MD, Ansaloni L, Chiarugi M, Tartaglia D, Ioannidis O, Sugrue M, Colak E, Hameed SM, Lampela H, Agnoletti V, McKee JL, Garraway N, Sartelli M, Ball CG, Parry NG, Voght K, Julien L, Kroeker J, Roberts DJ, Faris P, Tiruta C, Moore EE, Ammons LA, Anestiadou E, Bendinelli C, Bouliaris K, Carroll R, Ceresoli M, Favi F, Gurrado A, Rezende-Neto J, Isik A, Cremonini C, Strambi S, Koukoulis G, Testini M, Trpcic S, Pasculli A, Picariello E, Abu-Zidan F, Adeyeye A, Augustin G, Alconchel F, Altinel Y, Hernandez Amin LA, Aranda-Narvaez JM, Baraket O, Biffl WL, Baiocchi GL, Bonavina L, Brisinda G, Cardinali L, Celotti A, Chaouch M, Chiarello M, Costa G, de'Angelis N, De Manzini N, Delibegovic S, Di Saverio S, De Simone B, Dubuisson V, Fransvea P, Garulli G, Giordano A, Gomes C, Hayati F, Huang J, Ibrahim AF, Huei TJ, Jailani RF, Khan M, Luna AP, Malbrain MLNG, Marwah S, McBeth P, Mihailescu A, Morello A, Mulita F, Murzi V, Mohammad AT, Parmar S, Pak A, Wong MP, Pantalone D, Podda M, Puccioni C, Rasa K, Ren J, Roscio F, Gonzalez-Sanchez A, Sganga G, Scheiterle M, Slavchev M, Smirnov D, Tosi L, Trivedi A, Vega JAG, Waledziak M, Xenaki S, Winter D, Wu X, Zakaria AD, Zakaria Z. The unrestricted global effort to complete the COOL trial. World J Emerg Surg. 2023 May 11;18(1):33. doi: 10.1186/s13017-023-00500-z.

  PMID: 37170123 DERIVED

• 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.

  PMID: 32085778 DERIVED

• 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.

  PMID: 31404221 DERIVED

• 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.

  PMID: 29977328 DERIVED

• 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.

  PMID: 29636790 DERIVED

MeSH Terms

Conditions

Intraabdominal Infections; Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Andrew W Kirkpatrick, MD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew Kirkpatrick, MD

CONTACT

403-944-2888; andrew.kirkpatrick@ahs.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Research members in the laboratory will be blinded with participants' clinical data.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomization by blocks on a website.

Study Record Dates

• First Submitted: May 18, 2017
• First Posted: May 22, 2017
• Study Start: June 2, 2019
• Primary Completion: July 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 3, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)