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Closed or Open Abdomen for the Management of Abdominal Sepsis

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ClinicalTrials.gov Identifier: NCT03163095
Recruitment Status : Not yet recruiting
First Posted : May 22, 2017
Last Update Posted : October 10, 2018
Sponsor:
Collaborator:
Alberta Health Services
Information provided by (Responsible Party):
Andrew W Kirkpatrick, University of Calgary

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.


Condition or disease Intervention/treatment Phase
Abdominal Sepsis Abdominal Infection Device: Open Abdomen Management with ANPPT dressing Other: Closed Abdomen Management Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 550 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomization by blocks on a website.
Masking: Single (Outcomes Assessor)
Masking Description: Research members in the laboratory will be blinded with participants' clinical data.
Primary Purpose: Treatment
Official Title: Closed Versus Open Abdomen in the Surgical Treatment of Severe Secondary Peritonitis: a Randomized Controlled Clinical Trial
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Arm Intervention/treatment
Active Comparator: Open Abdomen Management with ANPPT dressing
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

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.


Sham Comparator: Closed Abdomen Management
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

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.





Primary Outcome Measures :
  1. The numbers of participants who are survival in hospital stay [ Time Frame: 90 days after participants enrolled in the study ]
    The rate of survival of participants in both arms


Secondary Outcome Measures :
  1. The days of intensive care unit stay [ Time Frame: 30 days after participants enrolled in the study ]
    The median length of days in ICU needed by participants in both arms

  2. The pg/ml of blood Interleukin-6 [ Time Frame: 72 hours after participants enrolled in the study ]
    The mean concentrations of blood IL-6 in participants in both arms



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03163095


Contacts
Contact: Andrew Kirkpatrick, MD 403-944-2888 andrew.kirkpatrick@ahs.ca

Locations
Canada, Alberta
Foothills Medical Centre
Calgary, Alberta, Canada, T2N 2T9
Sponsors and Collaborators
University of Calgary
Alberta Health Services
Investigators
Principal Investigator: Andrew W Kirkpatrick, MD University of Calgary

Publications of Results:
Sartelli M, Abu-Zidan FM, Catena F, Griffiths EA, Di Saverio S, Coimbra R, Ordoñez 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, Beltràn 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, Giménez 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, Leão P, Lee JG, Leon M, Lizarazu Pérez A, Lohsiriwat V, López-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, Sánchez de Molina ML, Seretis C, Shelat V, Simões 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.
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. Erratum in: Crit Care Med. 2008 Apr;36(4):1394-6.

Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Andrew W Kirkpatrick, Professor, University of Calgary
ClinicalTrials.gov Identifier: NCT03163095     History of Changes
Other Study ID Numbers: REB16-1588-the COOL study
First Posted: May 22, 2017    Key Record Dates
Last Update Posted: October 10, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Not shared.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Andrew W Kirkpatrick, University of Calgary:
sepsis
abdominal infection
open abdomen management
Negative pressure peritoneal therapy

Additional relevant MeSH terms:
Sepsis
Intraabdominal Infections
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes