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

NCT01410526 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2021-08-30

No results posted yet for this study

Summary

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.

Conditions

  • Abdominal Sepsis

Sponsors & Collaborators

  • Aristotle University Of Thessaloniki

    lead OTHER

Principal Investigators

  • Nick Michalopoulos, MD · 3rd Dpt of Surgery

  • Theodossis S Papavramidis, PhD · 3rd Dpt of Surgery

  • Spiros Papavramidis, Prof · 3rd Dpt of Surgery

  • Stella Arampatzi, MD · Dpt of Microbiology

  • Eudoxia Diza-Mataftsi, Prof · Dpt of microbiology

  • Ioannis Pliakos, MD · 3 dpt of Surgery

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2015-05-31
Completion
2015-08-31

Countries

  • Greece

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01410526 on ClinicalTrials.gov