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

Principal Investigator Statement: ...................................................... 1 Protocol Synopsis: ........................................................................ 2 Table of Content: ......................................................................... .4 1.0 Introduction: ...................................................................... 5 2.0 Techniques descriptions: ........................................................ 6 3.0 Objectives: ..........................................................................7 4.0 Design and study population: ................................................... 7 5.0 Study procedure: ................................................................. 8 6.0 Complications and adverse events: .......................................... 15 7.0 Statistical analysis: .............................................................. 15 8.0 Data monitoring plan: ........................................................ 16 9.0 Data confidentiality: ........................................................... 16 10.0 Funding: .......................................................................... 16 11.0 Ethics: ............................................................................. 16 12.0 Informed consent: ................................................................ 17 13.0 References: ....................................................................... 18

1.0 INTRODUCTION

Severe abdominal sepsis is defined as sepsis plus organ dysfunction caused by a condition deriving from the peritoneal cavity [1]. The essentials of the management of patients with severe sepsis remain unchanged and can be divided broadly into sepsis control, antimicrobial therapy and hemodynamic stabilization [2]. Infection control mainly involves surgical exploration and temporary or permanent resolution of the septic agent [3]. Open abdomen treatment remains one of the most valid approaches of patients with severe abdominal sepsis [4]. Open abdomen management is mandated to avoid abdominal compartment syndrome, in cases with inability to re-approximate the abdominal fascia regardless to viscera oedema and intra-abdominal pressure and in cases with unclear or inadequate source control [5]. Topical negative pressure with the abdominal vacuum-assisted closure (VAC) device has been introduced, providing a new option to manage an open abdomen [6-8].

Cytokines are a group of proteins produced by a variety of cells playing an active role in the immune system. Sepsis syndrome seems to result from overwhelming systemic inflammation which is caused by excessive release of cytokines into systemic circulation [9]. During the last decade many clinical studies assess the cytokines concentration in serum plasma in patients with SIRS and sepsis [10-13]. Despite the board study and analysis of cytokines response in serum plasma, literature is poor about peritoneum immune response in intra-abdominal sepsis [14-15], whereas the majority of these studies concerned patients with elective surgery [16-18].

This protocol is designed to assess the cytokines levels in the peritoneal cavity in severe intra-abdominal sepsis and to compare these levels with the corresponding values in serum plasma. Additionally, the cytokines values in serum plasma and peritoneum are compared between patients with and without sepsis that underwent major elective laparotomy (middle line incision >15cm). Moreover, cytokines levels are correlated to morbidity and mortality.