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

NCT01410526 | Completed DMC

• 1 other identifier: 1354_9/5/2011
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 1.To measure the peritoneal cytokines levels in patients with severe intra-abdominal sepsis.
2. 2.To correlate the cytokines levels in the abdominal cavity and the serum plasma.
3. 3.To correlate cytokines response in serum plasma and peritoneal fluid with mortality and morbidity.
4. 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. 5.To assess the microbial load in the abdominal cavity in patients with severe sepsis.
6. 6.To assess the biofilm formation in VAC polyurethane sponge.

Conditions

Abdominal Sepsis

Keywords

VAC; Severe abdominal sepsis; Peritoneal immune reaction; Peritonitis; Immune peritoneal reaction when abdominal sepsis is treated with VAC

Outcome Measures

Primary Outcomes (1)

• Measure peritoneal immune response to intra-abdominal sepsis

  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.

  5/2011-5/2013 (2 years)

Secondary Outcomes (1)

• General characteristics

  5/2011-5/2013 (2 years)

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

In all patients that the origin of sepsis confirmed pre-operative as abdominal, laparotomy will be required.

You may qualify if:

• Patient \> 18 years old
• 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.
• Patient or relatives signs and dates a written informed consent form (ICF) and indicates an understanding of the study procedures

You may not qualify if:

• Patient's Manheim Peritonitis Score \< 29
• Patient's pre-operative SOFA score \< 6
• The use of other temporary abdominal closure system
• Decease before the first VAC dressing change
• Patient is participating in another clinical trial which may affect this study's outcomes
• Patients with immune deficiency
• Documented seropositivity for human immunodeficiency virus (AIDS)
• Patient receiving steroids treatment for other medical condition
• Patient receiving chronic anti-inflammatory treatment
• Patient receiving anti- TNF treatment
• Pre-existing parechymal liver disease ( Cirrhosis - Child-Pugh C)
• Pregnancy

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead

Study Sites (1)

3rd Department of Surgery, AHEPA University Hospital

Thessaloniki, 54636, Greece

Location

Related Publications (2)

• 1.Calandra T, Cohne J. The international sepsis forum consensus conference on definitions of infection in the intensive care unit. Crit Care Med 2005;33:1538-48. 2.Pieracci F, Barie PS. Intrabdominal infections. Curr Opin Crit Care. 2007;13:440-9. 3.Ordoñez CA, Puyana JC. Management of peritonitis in the critically ill patient. Surg Clin North Am 2006;86:1323-49. 4.Stawicki SP, Brooks A, Bilski T et al. The concept of damage control: Extending paradigm to emergency general surgery. Injury 2008;39:93-101. 5.Duff JH, Moffat J. Abdominal sepsis managed by leaving abdomen open. Surgery. 1981;90(4):774-8. 6.Barker DE, Green JM, Maxwell RA, et al. Experience with vacuum-pack temporary abdominal wound closure in 258 trauma and general and vascular surgical patients. J Am Coll Surg 2007;204:784-92 7. Perez D, Wildi S, Demartines N et al. Prospective evaluation of vacuum-assisted closure in abdominal compartment syndrome and severe abdominal sepsis. J Am Coll Surg 2007;205:586-92. 8.Management of the Open Abdomen: From Initial Operation to Definitive Closure. Open abdomen advisory panel: Co-Editors: D. Vargo, J. D. Richardson. Advisory panel: A. Cambell, M. Chang, T. Fabian, M. Franz, M. Kaplan, F. Moore, R. L. Reed, B. Scott, R. Silverman. Am Surg. 2009;75:S1-22. 9.Blackwell TS, Christman JW. Sepsis and cytokines: current status. British J Anaesth. 1996;77:110-7. 10.Oberholzer A, Souza S, Tschoeke S et al. Plasma cytokine measurements augment prognostic scores as indicators of outcome in patients with severe sepsis. Shock. 2005;23(6):488-93.

  BACKGROUND

• 11.Cogos CA, Drosou E, Bassaris HP et al. Pro-versus anti- inflammatory cytokines profile in patients with severe sepsis: a marker for prognosis and future therapeutic options. J Infect Dis. 2000;181:176-80. 12.Dimopoulou I, Armaganidis A, Douka E et al. Tumour necrosis factor-alpha (TNFa) and interleukin-10 are crucial mediators in post-operative inflammatory response and determine the occurrence of complications after major abdominal surgery. Cytokine 2007;37:55-61. 13.Pettila V, Hynninen M, Takkunen O et al. Predictive value of procalcitonin and interleukin 6 in critically ill patients with suspected sepsis. Intensive Care Med. 2002;28:1220-5. 14.Scheingraber S, Bauerfeilnd F, Bohme J, Dralle H. Limits of peritoneal cytokine measure ements during abdominal lavage treatment for intra-abdominal sepsis. Am J Surg. 2001;18:301-8. 15.Jansson K, Redler B, Truedsson L et al. Intraperitoneal cytokine response after major surgery: higher postoperative intraperitoneal versus systemic cytokine levels suggest the gastrointestinal tract as the major source of the postoperative inflammatory reaction. Am J Surg. 2004;187:372-7 16.Decker D, Tolba R, Spinger W et al. Abdominal surgical interventions: local and systemic conseqouences for the immune system - a prospective study on elective gastrointestinal surgery. J Surg Research. 2005;126:12-8. 17.van Berge Henegouwen M, van der Poll T, van Deventer S, Gouma D. Peritoneal cytokine release after elective gastrointestinal surgery and postoperative complications. Am J Surg. 1998;175:311-6 18.Pedersen M, Qvist N, Bisgaard C et al. Peritoneal microdialysis. Early diagnosis of anastomotic leakage after low anterior resection for rectosigmoid cancer. Scan J Surg. 2009;98:148-54. 19.Pliakos I, Papavramidis TS, Mihalopoulos N et al. Vacuum assisted closure in severe abdominal sepsis with or without retention sutured sequential fascial closure: a clinical trial. Surgery. 2010;148(5):947-53.

  BACKGROUND

MeSH Terms

Conditions

Intraabdominal Infections; Peritonitis

Condition Hierarchy (Ancestors)

Infections; Peritoneal Diseases; Digestive System Diseases

Study Officials

• Nick Michalopoulos, MD

  3rd Dpt of Surgery

  PRINCIPAL INVESTIGATOR

• Theodossis S Papavramidis, PhD

  3rd Dpt of Surgery

  PRINCIPAL INVESTIGATOR

• Spiros Papavramidis, Prof

  3rd Dpt of Surgery

  STUDY CHAIR

• Stella Arampatzi, MD

  Dpt of Microbiology

  PRINCIPAL INVESTIGATOR

• Eudoxia Diza-Mataftsi, Prof

  Dpt of microbiology

  STUDY CHAIR

• Ioannis Pliakos, MD

  3 dpt of Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in Surgery

Study Record Dates

• First Submitted: July 5, 2011
• First Posted: August 5, 2011
• Study Start: May 1, 2011
• Primary Completion: May 1, 2015
• Study Completion: August 1, 2015
• Last Updated: August 30, 2021

Record last verified: 2021-08

Locations

GR (1)