Assessment of Peritoneal Immune Response in Patients With Severe Intra-abdominal Sepsis Managed With Laparostomy and Vacuum Assisted Closure (VAC)
Recruitment status was: Recruiting
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.
- To measure the peritoneal cytokines levels in patients with severe intra-abdominal sepsis.
- To correlate the cytokines levels in the abdominal cavity and the serum plasma.
- To correlate cytokines response in serum plasma and peritoneal fluid with mortality and morbidity.
- To compare cytokines results in serum plasma and peritoneal fluid between patients with severe intra-abdominal sepsis and patients undergoing major laparotomy without sepsis.
- To assess the microbial load in the abdominal cavity in patients with severe sepsis.
- To assess the biofilm formation in VAC polyurethane sponge.
|Study Design:||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)|
- Measure peritoneal immune response to intra-abdominal sepsis [ Time Frame: 5/2011-5/2013 (2 years) ] [ Designated as safety issue: No ]
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.
- General characteristics [ Time Frame: 5/2011-5/2013 (2 years) ] [ Designated as safety issue: No ]
- Microbial load in the abdominal cavity.
- Biofilm formation in VAC polyurethane sponge.
- Characteristics of the patients
|Study Start Date:||May 2011|
|Estimated Study Completion Date:||August 2013|
|Estimated Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
Patients with intra-abdominal sepsis treated with Vacuum Assisted Closure (VAC) system plus the dynamic sutures
Patients suffering major abdominal surgery
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01410526
|3rd Department of Surgery, AHEPA University Hospital|
|Thessaloniki, Greece, 54636|
|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|