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

This study is currently recruiting participants.
Verified May 2011 by Aristotle University Of Thessaloniki
Sponsor:
Information provided by:
Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier:
NCT01410526
First received: July 5, 2011
Last updated: August 4, 2011
Last verified: May 2011
History of Changes
  Purpose

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.

Condition
Abdominal Sepsis

Study Type: Observational
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)

Resource links provided by NLM:

MedlinePlus related topics: Sepsis
U.S. FDA Resources

Further study details as provided by Aristotle University Of Thessaloniki:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • General characteristics [ Time Frame: 5/2011-5/2013 (2 years) ] [ Designated as safety issue: No ]
    1. Microbial load in the abdominal cavity.
    2. Biofilm formation in VAC polyurethane sponge.
    3. Characteristics of the patients
    4. Mortality
    5. Morbidity.


Estimated Enrollment: 60
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)
Groups/Cohorts
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01410526

Contacts
Contact: Nick Michalopoulos, MD 00306974092401 nickos.michalopoulos@gmail.com

Locations
Greece
3rd Department of Surgery, AHEPA University Hospital Recruiting
Thessaloniki, Greece, 54636
Contact: Spiros Papavramidis, Prof     00302310994647     spapavra@med.auth.gr    
Principal Investigator: Michael Polyzonis, MD            
Principal Investigator: Vasiliki Tsavdaridou, MD            
Principal Investigator: Isaak Kesisoglou, Prof            
Sponsors and Collaborators
Aristotle University Of Thessaloniki
Investigators
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
  More Information

No publications provided

Responsible Party: Spiros Papavramidis/ Head of 3rd Department of Surgery, 3rd Department of Surgery
ClinicalTrials.gov Identifier: NCT01410526     History of Changes
Other Study ID Numbers: 1354_9/5/2011
Study First Received: July 5, 2011
Last Updated: August 4, 2011
Health Authority: Greece: Ethics Committee

Keywords provided by Aristotle University Of Thessaloniki:
VAC
Severe abdominal sepsis
Peritoneal immune reaction
Peritonitis
Immune peritoneal reaction when abdominal sepsis is treated with VAC

Additional relevant MeSH terms:
Sepsis
Toxemia
Infection
 Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on May 21, 2013