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?
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.
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
Start Date: May 2011
Completed Date: August 2013
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
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