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

Sponsor

Medical University of Graz (Other)

Overall Status

Completed

CT.gov ID

NCT03468803

Collaborator

Barmherzige Brueder Marschallgasse / Graz (Other)

Enrollment

Location

Arm

10.6

Actual Duration (Months)

4.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Invasive Candidiases	Diagnostic Test: Beta D Glucan test	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Mar 1, 2018

Actual Primary Completion Date :

Jan 17, 2019

Actual Study Completion Date :

Jan 17, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Beta D Glucan (BDG) in surgery Serial Beta D Glucan measurements in each patients before, during, and after surgery	Diagnostic Test: Beta D Glucan test Measurement of BDG before, during and after surgery

Arm

Intervention/Treatment

Experimental: Beta D Glucan (BDG) in surgery

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

Diagnostic Test: Beta D Glucan test

Measurement of BDG before, during and after surgery

Outcome Measures

Primary Outcome Measures

Levels of Beta D Glucan after surgery [after surgery up to day 5]
Measurement of Beta D Glucan after surgery in pg/ml

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of Graz	Graz	Stmk	Austria	8036

Sponsors and Collaborators

Medical University of Graz
Barmherzige Brueder Marschallgasse / Graz

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Robert Krause, MD, Univ.Prof.Dr., Medical University of Graz

ClinicalTrials.gov Identifier:

NCT03468803

Other Study ID Numbers:

30-043 ex 17/18

First Posted:

Mar 19, 2018

Last Update Posted:

Mar 21, 2019

Last Verified:

Mar 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Candidiasis

Candidiasis, Invasive

Study Results

No Results Posted as of Mar 21, 2019