Influence of Open and Laparoscopic Abdominal Surgery Involving the Intestinal Tract on Serum 1,3-ß-D-Glucan (BDG) Values

NCT03468803 | Completed

• 1 other identifier: 30-043 ex 17/18
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Candida species are both known to colonize physiologically mucosal surfaces in the human body without causing signs or symptoms of infection and to cause a wide variety of diseases, including mucocutaneous infections and potentially fatal invasive infections of the bloodstream or organs. Throughout the past decades, invasive fungal infections (IFIs) are of increasing importance even in non-neutropenic patients who are in need of treatment in intensive care units (ICU) or have undergone major surgeries. Several factors like parenteral nutrition, central venous catheters, broad spectrum antibiotics admission, disturbance of gastrointestinal mucosa integrity have been associated with an increased incidence of IFIs. Positive testing for 1,3-ß-D-Glucan (BDG) in serum is widely used to assess invasive fungal infections. It detects circulating BDG, which is part of the fungal cell wall of clinical relevant fungi such as Candida spp. and Aspergillus spp.. The issue of BDG kinetics after intestinal mucosal damage (e.g. mucositis or gut surgery) is poorly understood. Intestinal mucosal damage is characterized by a loss of integrity of the intestinal mucosal barrier and increasing translocations of bacterial and/or fungal commensals of the gastrointestinal tract. In abdominal surgery a key concern in serum BDG kinetics is the potential introduction of BDG from surgical sponges and gauze or mucosal damage due to surgical damage of the mucosal integrity. Compared to open abdominal surgery in laparoscopic abdominal surgery sponges and gauze are rarely used. As life-threatening intraabdominal candidiasis occurs in 30 to 40% of high-risk abdominal surgical intensive care unit (ICU) patients it is of utmost importance to obtain reliable BDG values for diagnosis or exclusion of invasive candidiasis.

Conditions

Invasive Candidiases

Outcome Measures

Primary Outcomes (1)

• Levels of Beta D Glucan after surgery

  Measurement of Beta D Glucan after surgery in pg/ml

  after surgery up to day 5

Study Arms (1)

Beta D Glucan (BDG) in surgery

EXPERIMENTAL

Serial Beta D Glucan measurements in each patients before, during, and after surgery

Diagnostic Test: Beta D Glucan test

Interventions

Beta D Glucan test DIAGNOSTIC_TEST

Measurement of BDG before, during and after surgery

Beta D Glucan (BDG) in surgery

Eligibility Criteria

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

You may qualify if:

• Elective open abdominal surgery involving the small and/or large colon and with surgical sectioning of intestinal mucosa
• Signed informed consent

You may not qualify if:

• Antibiotic therapy other than optional single shot surgical prophylaxis as clinically indicated
• Clinical or radiological or laboratory evidence of current infectious disease (i.e. temperature \>38°C, elevated C-reactive protein (CRP) \>5mg/dl, leukocytosis \>11400/μl, elevated neutrophiles \>78%) as assessed by the treating physician
• Subsequent invasive candidiasis (defined according to proposed European Organization for Research and Treatment of Cancer Mycoses study group \[EORTC/MSG\] definitions of fungal infections in ICU) or other complicating infectious disease after surgery within the 5 day observation time frame

Sponsors & Collaborators

• Medical University of Graz: lead
• Barmherzige Brueder Marschallgasse / Graz: collaborator

Study Sites (1)

Medical University of Graz

Graz, Stmk, 8036, Austria

Location

MeSH Terms

Conditions

Candidiasis, Invasive

Condition Hierarchy (Ancestors)

Candidiasis; Mycoses; Bacterial Infections and Mycoses; Infections; Invasive Fungal Infections

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Univ.Prof.Dr.

Study Record Dates

• First Submitted: March 12, 2018
• First Posted: March 19, 2018
• Study Start: March 1, 2018
• Primary Completion: January 17, 2019
• Study Completion: January 17, 2019
• Last Updated: March 21, 2019

Record last verified: 2019-03

Locations

AU (1)