Influence of Open and Laparoscopic Abdominal Surgery Involving the Intestinal Tract on Serum 1,3-ß-D-Glucan (BDG) Values
Primary Purpose
Invasive Candidiases
Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Beta D Glucan test
Sponsored by
About this trial
This is an interventional diagnostic trial for Invasive Candidiases
Eligibility Criteria
Inclusion Criteria:
- Elective open abdominal surgery involving the small and/or large colon and with surgical sectioning of intestinal mucosa
- Signed informed consent
Exclusion Criteria:
- Ongoing antifungal therapy for treatment of active fungal infection or antifungal therapy within 4 weeks prior to inclusion
- Antibiotic therapy other than optional single shot surgical prophylaxis as clinically indicated
- Ongoing Enterococcus sp. bacteremia or treatment of Enterococcus sp. bacteremia within 4 weeks prior to inclusion
- 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
- Immunoglobulin, blood or blood products (i.e. thrombocytes, fresh frozen plasma) administration within 4 weeks prior to inclusion
- Abdominal surgery (laparoscopic or open) or other major surgeries (e.g. aortocoronary bypass) within 4 weeks prior to inclusion
- 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
Sites / Locations
- Medical University of Graz
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Beta D Glucan (BDG) in surgery
Arm Description
Serial Beta D Glucan measurements in each patients before, during, and after surgery
Outcomes
Primary Outcome Measures
Levels of Beta D Glucan after surgery
Measurement of Beta D Glucan after surgery in pg/ml
Secondary Outcome Measures
Full Information
NCT ID
NCT03468803
First Posted
March 12, 2018
Last Updated
March 19, 2019
Sponsor
Medical University of Graz
Collaborators
Barmherzige Brueder Marschallgasse / Graz
1. Study Identification
Unique Protocol Identification Number
NCT03468803
Brief Title
Influence of Open and Laparoscopic Abdominal Surgery Involving the Intestinal Tract on Serum 1,3-ß-D-Glucan (BDG) Values
Official Title
Influence of Open and Laparoscopic Abdominal Surgery Involving the Intestinal Tract on Serum 1,3-ß-D-Glucan (BDG) Values
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
January 17, 2019 (Actual)
Study Completion Date
January 17, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Graz
Collaborators
Barmherzige Brueder Marschallgasse / Graz
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Invasive Candidiases
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Beta D Glucan (BDG) in surgery
Arm Type
Experimental
Arm Description
Serial Beta D Glucan measurements in each patients before, during, and after surgery
Intervention Type
Diagnostic Test
Intervention Name(s)
Beta D Glucan test
Intervention Description
Measurement of BDG before, during and after surgery
Primary Outcome Measure Information:
Title
Levels of Beta D Glucan after surgery
Description
Measurement of Beta D Glucan after surgery in pg/ml
Time Frame
after surgery up to day 5
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Elective open abdominal surgery involving the small and/or large colon and with surgical sectioning of intestinal mucosa
Signed informed consent
Exclusion Criteria:
Ongoing antifungal therapy for treatment of active fungal infection or antifungal therapy within 4 weeks prior to inclusion
Antibiotic therapy other than optional single shot surgical prophylaxis as clinically indicated
Ongoing Enterococcus sp. bacteremia or treatment of Enterococcus sp. bacteremia within 4 weeks prior to inclusion
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
Immunoglobulin, blood or blood products (i.e. thrombocytes, fresh frozen plasma) administration within 4 weeks prior to inclusion
Abdominal surgery (laparoscopic or open) or other major surgeries (e.g. aortocoronary bypass) within 4 weeks prior to inclusion
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
Facility Information:
Facility Name
Medical University of Graz
City
Graz
State/Province
Stmk
ZIP/Postal Code
8036
Country
Austria
12. IPD Sharing Statement
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Influence of Open and Laparoscopic Abdominal Surgery Involving the Intestinal Tract on Serum 1,3-ß-D-Glucan (BDG) Values
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