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Assessment of Peritoneal Immune Response in Patients With Severe Intra-abdominal Sepsis Managed With Laparostomy and Vacuum Assisted Closure (VAC)

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ClinicalTrials.gov Identifier: NCT01410526
Recruitment Status : Completed
First Posted : August 5, 2011
Last Update Posted : August 30, 2021
Information provided by (Responsible Party):
Papavramidis Theodossis, Aristotle University Of Thessaloniki

Brief Summary:

Protocol Synopsis

Protocol title: Assessment of peritoneal immune response in patients with severe intra-abdominal sepsis managed by laparostomy and VAC

Purpose: Assessment of peritoneal immune response in patients with severe intra-abdominal sepsis

Design: Prospective, single-center study

Patient Population: Male or female adults (>18 years) with severe intra-abdominal sepsis

No. of Subjects: 60 patients divided into two groups, 30 patients with severe intra-operative sepsis and 30 patients without sepsis scheduled to undergo major abdominal operations (middle line incision>15cm). The study is estimated up to 2 year to enroll

Duration of Follow-up: Follow-up will be performed daily while hospitalized, until patient discharged or deceased.


  1. To measure the peritoneal cytokines levels in patients with severe intra-abdominal sepsis.
  2. To correlate the cytokines levels in the abdominal cavity and the serum plasma.
  3. To correlate cytokines response in serum plasma and peritoneal fluid with mortality and morbidity.
  4. To compare cytokines results in serum plasma and peritoneal fluid between patients with severe intra-abdominal sepsis and patients undergoing major laparotomy without sepsis.
  5. To assess the microbial load in the abdominal cavity in patients with severe sepsis.
  6. To assess the biofilm formation in VAC polyurethane sponge.

Condition or disease
Abdominal Sepsis

Show Show detailed description

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Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Assessment of Peritoneal Immune Response in Patients With Severe Intra-abdominal Sepsis Managed With Laparostomy and Vacuum Assisted Closure (VAC)
Study Start Date : May 2011
Actual Primary Completion Date : May 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

VAC group
Patients with intra-abdominal sepsis treated with Vacuum Assisted Closure (VAC) system plus the dynamic sutures
Control group
Patients suffering major abdominal surgery

Primary Outcome Measures :
  1. Measure peritoneal immune response to intra-abdominal sepsis [ Time Frame: 5/2011-5/2013 (2 years) ]

    Possible alterations of the following factors in the blood and the periotoneal fluid:

    CRP, PCT, Lectin Binding Protein (LBP),IL 1α, IL 1β, IL6, IL8, IL12, IL 10, IL 18, INF-γ, TNF-α, PGF-B, PAF, FGF-β, C5q, C3q, ICAM-I (CD54),Fractalkine, CCL6.

Secondary Outcome Measures :
  1. General characteristics [ Time Frame: 5/2011-5/2013 (2 years) ]
    1. Microbial load in the abdominal cavity.
    2. Biofilm formation in VAC polyurethane sponge.
    3. Characteristics of the patients
    4. Mortality
    5. Morbidity.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
In all patients that the origin of sepsis confirmed pre-operative as abdominal, laparotomy will be required.

Inclusion Criteria:

  1. Patient > 18 years old
  2. 30 patients with severe abdominal sepsis in order to form the study group and 30 patients without sepsis undergoing major elective surgery (middle line incision >15cm) to form the control group.
  3. Patient or relatives signs and dates a written informed consent form (ICF) and indicates an understanding of the study procedures

Exclusion Criteria:

  1. Patient's Manheim Peritonitis Score < 29
  2. Patient's pre-operative SOFA score < 6
  3. The use of other temporary abdominal closure system
  4. Decease before the first VAC dressing change
  5. Patient is participating in another clinical trial which may affect this study's outcomes
  6. Patients with immune deficiency
  7. Documented seropositivity for human immunodeficiency virus (AIDS)
  8. Patient receiving steroids treatment for other medical condition
  9. Patient receiving chronic anti-inflammatory treatment
  10. Patient receiving anti- TNF treatment
  11. Pre-existing parechymal liver disease ( Cirrhosis - Child-Pugh C)
  12. Pregnancy

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): NCT01410526

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3rd Department of Surgery, AHEPA University Hospital
Thessaloniki, Greece, 54636
Sponsors and Collaborators
Aristotle University Of Thessaloniki
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Principal Investigator: Nick Michalopoulos, MD 3rd Dpt of Surgery
Principal Investigator: Theodossis S Papavramidis, PhD 3rd Dpt of Surgery
Study Chair: Spiros Papavramidis, Prof 3rd Dpt of Surgery
Principal Investigator: Stella Arampatzi, MD Dpt of Microbiology
Study Chair: Eudoxia Diza-Mataftsi, Prof Dpt of microbiology
Principal Investigator: Ioannis Pliakos, MD 3 dpt of Surgery
1.Calandra T, Cohne J. The international sepsis forum consensus conference on definitions of infection in the intensive care unit. Crit Care Med 2005;33:1538-48. 2.Pieracci F, Barie PS. Intrabdominal infections. Curr Opin Crit Care. 2007;13:440-9. 3.Ordoñez CA, Puyana JC. Management of peritonitis in the critically ill patient. Surg Clin North Am 2006;86:1323-49. 4.Stawicki SP, Brooks A, Bilski T et al. The concept of damage control: Extending paradigm to emergency general surgery. Injury 2008;39:93-101. 5.Duff JH, Moffat J. Abdominal sepsis managed by leaving abdomen open. Surgery. 1981;90(4):774-8. 6.Barker DE, Green JM, Maxwell RA, et al. Experience with vacuum-pack temporary abdominal wound closure in 258 trauma and general and vascular surgical patients. J Am Coll Surg 2007;204:784-92 7. Perez D, Wildi S, Demartines N et al. Prospective evaluation of vacuum-assisted closure in abdominal compartment syndrome and severe abdominal sepsis. J Am Coll Surg 2007;205:586-92. 8.Management of the Open Abdomen: From Initial Operation to Definitive Closure. Open abdomen advisory panel: Co-Editors: D. Vargo, J. D. Richardson. Advisory panel: A. Cambell, M. Chang, T. Fabian, M. Franz, M. Kaplan, F. Moore, R. L. Reed, B. Scott, R. Silverman. Am Surg. 2009;75:S1-22. 9.Blackwell TS, Christman JW. Sepsis and cytokines: current status. British J Anaesth. 1996;77:110-7. 10.Oberholzer A, Souza S, Tschoeke S et al. Plasma cytokine measurements augment prognostic scores as indicators of outcome in patients with severe sepsis. Shock. 2005;23(6):488-93.
11.Cogos CA, Drosou E, Bassaris HP et al. Pro-versus anti- inflammatory cytokines profile in patients with severe sepsis: a marker for prognosis and future therapeutic options. J Infect Dis. 2000;181:176-80. 12.Dimopoulou I, Armaganidis A, Douka E et al. Tumour necrosis factor-alpha (TNFa) and interleukin-10 are crucial mediators in post-operative inflammatory response and determine the occurrence of complications after major abdominal surgery. Cytokine 2007;37:55-61. 13.Pettila V, Hynninen M, Takkunen O et al. Predictive value of procalcitonin and interleukin 6 in critically ill patients with suspected sepsis. Intensive Care Med. 2002;28:1220-5. 14.Scheingraber S, Bauerfeilnd F, Bohme J, Dralle H. Limits of peritoneal cytokine measure ements during abdominal lavage treatment for intra-abdominal sepsis. Am J Surg. 2001;18:301-8. 15.Jansson K, Redler B, Truedsson L et al. Intraperitoneal cytokine response after major surgery: higher postoperative intraperitoneal versus systemic cytokine levels suggest the gastrointestinal tract as the major source of the postoperative inflammatory reaction. Am J Surg. 2004;187:372-7 16.Decker D, Tolba R, Spinger W et al. Abdominal surgical interventions: local and systemic conseqouences for the immune system - a prospective study on elective gastrointestinal surgery. J Surg Research. 2005;126:12-8. 17.van Berge Henegouwen M, van der Poll T, van Deventer S, Gouma D. Peritoneal cytokine release after elective gastrointestinal surgery and postoperative complications. Am J Surg. 1998;175:311-6 18.Pedersen M, Qvist N, Bisgaard C et al. Peritoneal microdialysis. Early diagnosis of anastomotic leakage after low anterior resection for rectosigmoid cancer. Scan J Surg. 2009;98:148-54. 19.Pliakos I, Papavramidis TS, Mihalopoulos N et al. Vacuum assisted closure in severe abdominal sepsis with or without retention sutured sequential fascial closure: a clinical trial. Surgery. 2010;148(5):947-53.

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Responsible Party: Papavramidis Theodossis, Associate Professor in Surgery, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier: NCT01410526    
Other Study ID Numbers: 1354_9/5/2011
First Posted: August 5, 2011    Key Record Dates
Last Update Posted: August 30, 2021
Last Verified: August 2021
Keywords provided by Papavramidis Theodossis, Aristotle University Of Thessaloniki:
Severe abdominal sepsis
Peritoneal immune reaction
Immune peritoneal reaction when abdominal sepsis is treated with VAC
Additional relevant MeSH terms:
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Intraabdominal Infections
Systemic Inflammatory Response Syndrome
Pathologic Processes