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
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.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||60 participants|
|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|
Patients with intra-abdominal sepsis treated with Vacuum Assisted Closure (VAC) system plus the dynamic sutures
Patients suffering major abdominal surgery
- 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.
- General characteristics [ Time Frame: 5/2011-5/2013 (2 years) ]
- Microbial load in the abdominal cavity.
- Biofilm formation in VAC polyurethane sponge.
- Characteristics of the patients
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
|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|