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

Abdominal Sepsis research study

What is the primary objective of this study?

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. Endpoints: 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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Abdominal Sepsis

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

VAC groupPatients with intra-abdominal sepsis treated with Vacuum Assisted Closure (VAC) system plus the dynamic sutures

Control groupPatients suffering major abdominal surgery

Study Status

Unknown status

Start Date: May 2011

Completed Date: August 2013

Phase:

Type: Observational

Design:

Primary Outcome: Measure peritoneal immune response to intra-abdominal sepsis

Secondary Outcome: General characteristics

Study sponsors, principal investigator, and references

Principal Investigator: Nick Michalopoulos, MD

Lead Sponsor: Aristotle University Of Thessaloniki

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01410526

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.OrdoƱez 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.

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